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2ASDBMA-0382-5MA-0382-5 J8 to J9-11 Assembly

CMR Surgical Ltd.
MA-0382-5 J8 to J9-11 Assembly - FCC ID 2ASDBMA-0382-5 - CMR Surgical Ltd.
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Application Details

Equipment Class
DXX - Part 15 Low Power Communication Device Transmitter
Date of Grant
Dec 15, 2020
Application Purpose
Original Equipment
Date of Application
Dec 15, 2020
Equipment Note
MA-0382-5 J8 to J9-11 Assembly
Frequency Range
13.56000000 - 13.56000000
Company
CMR Surgical Ltd.
Country
United Kingdom

Documents & Files

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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RF Exposure Info

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Test Report

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Test Setup Photos

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Cover Letter(s)

Registered Address: CMR Surgical Limited, 1 Evolution Business Park, Milton Road, Impington, Cambridge, CB24 9NG, UK SR-0208v2.0 RFID Module FCC Cover Letter cmrsurgical.com CMR Surgical Ltd 1 Evolution Business Park Milton Road Cambridge CB24 9NG UK Cover Letter November 3, 2020 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: MA-0382 J8 to J9-11 Assembly FCC Submission FCC ID: 2ASDBMA-0382-5 To whom it may concern, We, CMR Surgical declare that the MA-0382-5 J8 to J9-11 Assembly meets the requirements of a limited module under the FCC Rules, Part 15C. We attest to the fact that procedures of the Declaration of Conformity have been applied to the module. The module has been evaluated by Element Materials Technology. The evidence provided in this application demonstrates compliance. In case of any questions concerning this application please contact Chanel Allen-Megahey, email [email protected] Yours faithfully, CMR Surgical Ltd Chanel Allen-Megahey Head of Regulatory

Cover Letter(s)

CSF410-TCB 6.0 Page 1 of 5 FORM CSF410-TCB FCC APPLICATION FORM This form constitutes the certification agreement between Element Materials Technology and the Applicant and is required for every application. Please ensure accuracy when completing this form because the content is used to make the FCC upload to the FCC eFiling system. Please complete the relevant sections in the tables below. Guidance on each numbered section of this form is provided at the end of the document. Please contact Element if you have any further questions. Applicant business details 1. Applicant’s complete, legal business name. CMR Surgical Ltd 2. Applicant’s mailing address (Line 1) 1 Evolution Business Park 3. Applicant’s mailing address (Line 2) Milton Road 4. City, State, Zip (or postal code) Cambridge, Cambridgeshire, CB24 9NG 5. Name, Title of Person registered with the FCC to receive the grant. Chanel Allen-Megahey 6. Phone No. (Area/Country /City Code, Number, Ext). +44 7845 014416 7. Fax No. (Area/Country/City Code, Number, Ext. 8. Internet email address [email protected] 9. Applicants FRN # (FCC registered number) 0030112320 Authorised agent details Only to be completed where a third party is used to make an application on behalf of the Applicant 10. Name, Title 11. Mailing address (Line 1) 12. City, State, Zip (or postal code) 13. Phone No. (Area/Country /City Code, Number, Ext). 14. Internet email address Product details 15. Equipment model MA-0382-5 J8 to J9-11 Assembly 16. FCC ID Number GRANTEE CODE 2ASDB 17. FCC ID equipment code (Max. 14 Chars.) MA-0382-5 18. FCC ID Rule part. (15.249, 15.247, etc.) 15.225 FORM CSF410-TCB FCC APPLICATION FORM CSF410-TCB 6.0 Page 2 of 5 19. Type of grant ☒Original Grant ☐ Class II Permissive Change ☐ Class III Permissive Change ☐ Change in ID (Provide original FCC ID number and grant date (yyyy/mm/dd: ) 20. Seeking modular approval? ☒ Yes ☐ No 21. Contain a pre-approved radio module? ☐ Yes ☒ No If yes, FCC ID of pre-approved module: 22. Are there provisions for using this radio within 20 cm of the head or torso? (belt clips, holster, headset, etc.) ☒ Yes ☐ No Other information 23. Do you wish to hold some information permanently confidential? ☒ Yes ☐ No 24. Do you wish to hold some information confidential short-term? ☐ Yes ☒ No Notes or comments Free field FORM CSF410-TCB FCC APPLICATION FORM CSF410-TCB 6.0 Page 3 of 5 FCC application and signature Read each certification carefully before answering and signing this application. WILLFUL FALSE STATEMENTS MADE ON THIS FORM ARE PUNISHABLE BY FINE AND/OR IMPRISONMENT (U.S. CODE, TITLE 18, SECTION 1001), AND/OR REVOCATION OF ANY STATION LICENSE OR CONSTRUCTION PERMIT (U.S. CODE, TITLE 47, SECTION 312(a)(1)), AND/OR FORFEITURE (U.S. CODE, TITLE 47, SECTION 503). 25. SECTION 5301 (ANTI-DRUG ABUSE) CERTIFICATION The applicant must certify that neither the applicant nor any party to the application is subject to a denial of Federal benefits, that include FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. §862 because of a conviction for possession or distribution of a controlled substance. See 47 CFR 1.2002(b) for the definition of a “party” for these purposes. Does the applicant or authorized agent so certify? ☒ Yes ☐ No 26. NOT PREVIOUSLY SUBMITTED NOR DENIED I certify that this product has not been previously submitted to the FCC nor to another TCB for certification. I further certify that this product has not previously been dismissed nor denied by the FCC nor by another TCB. 27. APPLICANT/AGENT ATTESTATION I certify that I am authorized to sign this application. All of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. In accepting a Grant of Equipment Authorization issued by the TCB as a result of the representations made in this application, the applicant is responsible for (1) labeling the equipment with the exact FCC ID specified in this application, (2) compliance statement labeling pursuant to the applicable rules, and (3) compliance of the equipment with the applicable technical rules. If the applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCC’s technical requirements. Authorizing an agent to sign this application, is done solely at the applicant’s discretion; however, the applicant remains responsible for all statements in this application. If an agent has signed this application on behalf of the applicant, a written letter of authorization which includes information to enable the agent to respond to the above Section 5301 (Anti-Drug Abuse) Certification statement has been provided by the applicant. It is understood that the letter of authorization must be submitted to the FCC upon request, and that the TCB reserves the right to contact the applicant directly at any time. 28. IEC/ISO 17065 REQUIREMENTS By signing this application, the applicant agrees to the following requirements and conditions: a. The applicant will always comply with the relevant provisions of the certification programme, and the requirements of the regulatory body under which certification is granted, including implementing appropriate changes when they are communicated by the Element Certification Body. b. If the certification applies to ongoing production, the certified product continues to fulfil the product requirements. c. The applicant will make all necessary arrangements for: i) the conduct of the evaluation, including provision for examining documentation and records and access to and access to the relevant equipment, location(s), area(s), personnel, and applicant's subcontractors; ii) investigation of complaints; iii) the participation of observers, if applicable. d. The applicant makes claims regarding certification consistent with the scope of certification. …

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Cover Letter(s)

Registered Address: CMR Surgical Limited, 1 Evolution Business Park, Milton Road, Impington, Cambridge, CB24 9NG, UK SR-0208v1.0 RFID Module FCC Confidentiality Request cmrsurgical.com CMR Surgical Ltd 1 Evolution Business Park Milton Road Cambridge CB24 9NG UK Request for Confidentiality Letter - FCC October 21, 2020 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Request for confidentiality FCC ID: 2ASDBMA-0382-5 To whom it may concern, We hereby respectfully request that under the provision of 47 CFR 0.459 and 0.457(d) the documents listed below and attached with this application for certification be provided with confidential status.  Operational Description  Block Diagram  Schematics  Track and Component Layout Drawings  Parts List  User’s Manual  Internal Photographs  Antenna Information Any exhibit / information for which we have requested confidentiality, but which may not be accorded such treatment by the FCC, should be returned to us. The documents listed above contain trade secrets that are treated as confidential by us. Substantial competitive harm to us could result should they be made available to the public. The device meets the special conditions laid down in KDB 726920 D01 v01r02, clause II.3)a)+b) for Long- Term Confidentiality of Internal Photos and User Manual, which we hereby request. The circuit board and internal components are not accessible to end users since the device is only to be used and serviced by CMR Surgical. The device is not accessible to the public since the device is intended for installation wholly into end Registered Address: CMR Surgical Limited, 1 Evolution Business Park, Milton Road, Impington, Cambridge, CB24 9NG, UK SR-0208v1.0 RFID Module FCC Confidentiality Request cmrsurgical.com products. The manual contains proprietary technical information intended for professional technicians of CMR Surgical only. The device and user manual are not for sale and is for internal use only. Yours faithfully, CMR Surgical Ltd Chanel Allen-Megahey Head of Regulatory

External Photos

Registered Address: CMR Surgical Limited, 1 Evolution Business Park, Milton Road, Impington, Cambridge, CB24 9NG SR-0208v1.0 External Photographs cmrsurgical.com External Photographs Registered Address: CMR Surgical Limited, 1 Evolution Business Park, Milton Road, Impington, Cambridge, CB24 9NG SR-0208v1.0 External Photographs cmrsurgical.com Registered Address: CMR Surgical Limited, 1 Evolution Business Park, Milton Road, Impington, Cambridge, CB24 9NG SR-0208v1.0 External Photographs cmrsurgical.com

ID Label/Location Info

Registered Address: CMR Surgical Limited, 1 Evolution Business Park, Milton Road, Impington, Cambridge, CB24 9NG SR-0208v1.0 FCC ID Label and Location cmrsurgical.com FCC ID & IC Label Artwork FCC ID: 2ASDBMA-0382-5 Label Artwork: Font: Open Sans Size: 4.0pt Drawing of label not to scale Label Position: 17.5mm 5mm FCC ID: 2ASDBMA-0382-5

RF Exposure Info

MPE Calculation Prediction of MPE limit at a given distance For purposes of these requirements mobile devices are defined by the FCC as transmitters designed to be used in other than fixed locations and to generally be used in such a way that a separation distance of at least 20 centimeters is normally maintained between radiating structures and the body of the user or nearby persons. These devices are normally evaluated for exposure potential with relation to the MPE limits. As the 20 cm separation specified under FCC rules may not be achievable under normal operation of the EUT, an RF exposure calculation is needed to show the minimum distance required to be less than the power density limit, as required under FCC rules. Equation from IEEE C95.1 Where: S = power density R = distance to the centre of radiation of the antenna EIRP = EUT Maximum power Result Channel Frequency (MHz) EIRP (mW) Power density limit (S) (mW/cm 2 ) Distance (R) required to be less than the power density limit (cm) 13.56 0.000000014 1.0 0.0001 ππ 4 arranged-re 4 2 S EIRP R R EIRP S==

RF Exposure Info

General SAR test reduction & exclusion guidance KDB 447498 Section 4.3 General SAR test reduction and exclusion guidance For Standalone SAR exclusion consideration, when SAR Exclusion Threshold requirement in KDB 447498 is satisfied, standalone SAR evaluation for general population exposure conditions by measurement or numerical simulation is not required. The SAR Test Exclusion Threshold for frequencies below 100 MHz, and for test separation distance of ≤ 50 mm, is determined as follows. SAR Exclusion Threshold (SARET) = [(NT x TSD A) / √ 0.1] x [1 + Log (100 / F MHz )] x 1/2 Where, NT = Numeric Threshold (3.0 for 1-g SAR and 7.5 for 10-g SAR) TSD A = 50 mm f MHz = Transmit frequency in MHz Frequency (MHz) EIRP * (mW) SAR Exclusion Threshold at 5 mm (mW) SAR Evaluation 13.56 0.000000014 443.0 Not Required * Antenna Gain is unknown, so EIRP was used, instead of conducted power. Therefore standalone SAR evaluation for general population exposure conditions by measurement or numerical simulation is not required.

Test Report

RF914 6.0 Report on the Radio Testing For CMR Surgical Limited on Versius RFID Section Report no. TRA-044411-45-02C 6 November 2020 RF914 6.0 REPORT ON THE RADIO TESTING OF A CMR Surgical Limited Versius RFID Section WITH RESPECT TO SPECIFICATION FCC 47CFR 15.225 TEST DATE: 2020-09-24 to 2020-09-29 Tested and Written by: A Tosif Radio Test Engineer Approved by: J Charters Lab Manager Date: 6 November 2020 Disclaimers: [1] THIS DOCUMENT MAY BE REPRODUCED ONLY IN ITS ENTIRETY AND WITHOUT CHANGE [2] THE RESULTS CONTAINED IN THIS DOCUMENT RELATE ONLY TO THE ITEM(S) TESTED Report Number: TRA-044411-45-02C Issue: C Report Number: TRA-044411-45-02C RF914 6.0 Page 3 of 31 1 Revision Record Issue Number Issue Date Revision History A 1 October 2020 Original B 5 November 2020 Section 2 updated C 6 November 2020 Sections 7.4 and 15.6 updated Report Number: TRA-044411-45-02C RF914 6.0 Page 4 of 31 2 Summary TEST REPORT NUMBER: TRA-044411-45-02C WORKS ORDER NUMBER: TRA-044411-08 PURPOSE OF TEST: Certification TEST SPECIFICATION: 47CFR15.225 EQUIPMENT UNDER TEST (EUT): Versius RFID Section FCC IDENTIFIER: 2ASDBMA-0382-5 MANUFACTURER/AGENT: CMR Surgical Limited ADDRESS: Unit 2, Crome Lea Business Park, Madingley Road, Cambridge, CB23 7PH United Kingdom CLIENT CONTACT: Andrew Thompson  +44 (0)7864 922474  [email protected] ORDER NUMBER: PO-017344v2.0 TEST DATE: 2020-09-24 to 2020-09-29 TESTED BY: A Tosif Element Report Number: TRA-044411-45-02C RF914 6.0 Page 5 of 31 2.1 Test Summary Test Method and Description Requirement Clause, 47CFR15 Applicable to this equipment Result / Note Radiated spurious emissions, below 30 MHz 15.225(d) Pass Radiated spurious emissions 15.209 Pass AC power line conducted emissions 15.207 Pass Occupied bandwidth 15.215(c) Pass Field strength of fundamental 15.225(a), (b) and (c) Pass Frequency stability 15.225(e) Pass Notes: The results contained in this report relate only to the items tested, in the condition at time of test, and were obtained in the period between the date of initial receipt of samples and the date of issue of the report. The apparatus was set up and exercised using the configurations, modes of operation and arrangements defined in this report only. Any modifications made are identified in Section 8 of this report. Particular operating modes, apparatus monitoring methods and performance criteria required by the standards tested to have been performed except where identified in Section 5.2 of this test report (Deviations from Test Standards). Report Number: TRA-044411-45-02C RF914 6.0 Page 6 of 31 3 Contents 1 Revision Record ............................................................................................................................................... 3 2 Summary .......................................................................................................................................................... 4 2.1 Test Summary ......................................................................................................................................... 5 3 Contents ........................................................................................................................................................... 6 4 Introduction ....................................................................................................................................................... 7 5 Test Specifications ........................................................................................................................................... 8 5.1 Normative References ............................................................................................................................. 8 5.2 Deviations from Test Standards .............................................................................................................. 8 6 Glossary of Terms ............................................................................................................................................ 9 7 Equipment under Test .................................................................................................................................... 10 7.1 EUT Identification .................................................................................................................................. 10 7.2 System Equipment ................................................................................................................................. 10 7.3 EUT Mode of Operation ......................................................................................................................... 10 7.4 EUT Radio Parameters .......................................................................................................................... 10 7.5 EUT Description .................................................................................................................................... 10 8 Modifications ................................................................................................................................................... 11 9 EUT Test Setup Photographs ......................................................................................................................... 12 10 General Technical Parameters ....................................................................................................................... 14 10.1 Normal Conditions ................................................................................................................................. 14 10.2 Varying Test Conditions ......................................................................................................................... 14 11 Radiated emissions below 30 MHz ................................................................................................................. 15 11.1 Definitions ................................................................…

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Test Setup Photos

          

Contact Information

Applicant

Stephen Smith
[email protected]+44 1223 755421Fax: + 44 1223 755300

Test Firm

Element Materials Technology Warwick LtdKeith Wright
[email protected]00-44-1926-478478Fax: 00-44-1926-478479

Technical Specifications

#Rule PartsFrequency RangePower Output
115C13.56 MHz - 13.56 MHz-
Modular Type
Limited Single Modular Approval
Confidentiality
Long Term
Grant Notes
Limited single modular approval. This grant is valid only when the module is installed in the end products of the grantee under their control as explained in this filing. Marketing this module to 3rd parties and the general public is prohibited. The host integrator must follow the integration instructions provided by the module manufacturer and ensure that the composite-system end product complies with the FCC requirements by a technical assessment or evaluation to the FCC rules and to KDB Publication 996369. Grantee must ensure that the end user has no instructions to remove or install this module. End-users must be provided with transmitter operating conditions for satisfying RF exposure compliance requirements. Co-location of this module with other transmitters that operate simultaneously are required to be evaluated using the FCC multi-transmitter procedures.