2A3JW-EM25Sapphire Connect

Eitan Medical Ltd. Attestation Statements Not Covered Entity Applicant &Not Covered Equipment To: Federal Communications CommissionDate: Dec. 15, 25 7435 Oakland Mills Road, Columbia, MD 21046, USA Ref: Information Required by Section 2.911(d)(5)(i)& (ii) FCC ID:2A3JW-EM25 Eitan Medical Ltd. certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List, established pursuant to § 1.50002 of reference chapter, as an entity producing “covered” communication equipment. The equipment for which authorization is sought is not “covered” telecommunications equipment and video surveillance equipment produced by entities identified on the Commission’s Covered List that prohibited from receiving an equipment authorization pursuant to section§ 2.903of the FCC rules. Sincerely yours, Applicant Signature: Printed Name: Guy Hadar Title: EVP, Corporate Development and General Counsel Tel.: 054-4736672 Email: [email protected]

Eitan Medical Ltd. 1| P a g e Attestation Statements To: Federal Communications Commission Date: Dec. 15, 25 7435 Oakland Mills Road, Columbia, MD 21046, USA Subject: Attestation of Compliance with FCC Covered List Software Requirements FCC ID: 2A3JW-EM25 Product Name: Sapphire Connect This letter serves as an attestation that the equipment identified above ☐ is / ☒ is not (select one) "covered" software as defined under the Federal Communications Commission (FCC) Covered List requirements, as outlined in FCC 22-84 and KDB 986446. Specifically, the undersigned certifies that the equipment for which authorization is sought: 1. Does not contain cybersecurity or anti-virus software produced or provided by Kaspersky Lab, Inc. or any of its successors, assignees, parents, subsidiaries, affiliates, or any entity that has rebranded or relabeled software produced by the aforementioned entities. 2. Does not have the capability to store, run, or deliver any software identified on the FCC Covered List, including but not limited to cybersecurity and anti-virus software. To support this attestation, the appendixevaluation documentation has been prepared and is included in the certification filing. This attestation is based on a thorough evaluation of the device's design, functionality, and software environment. The undersigned affirms that the information provided is accurate and complete to the best of their knowledge. Sincerely yours, Applicant Signature Printed Name: Guy Hadar Title: EVP, Corporate Development and General Counsel Tel.: 054-4736672 Email: [email protected] Eitan Medical Ltd. 2| P a g e Evaluation regarding to the Covered List Software: Compliance Methodology Evaluation Process Results Device is Inherent compliance  The Chipset(s) used is limited to run the Cybersecurity or anti-virus software. Compliance  The Memory used is limited to run the Cybersecurity or anti-virus software. Compliance  There is storage capacitylimitation for store or install the Cybersecurity or anti-virus software. Compliance  Operatingsystem used is limited to run, install or deliver the Cybersecurity or anti-virus software. Compliance

U.S. Agent Designation for Service of Process - Certification Attestation Letter Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA ATTN.: Reviewing Engineer FCC ID: 2A3JW-EM25 FRN of applicant: 0031574387 Per section 2.911(d)(7) of the FCC rules, Eitan Medical Ltd. certifies that the equipment for which authorization is sought is designated to the following U.S. agent* for service of process: Company Name: Noa Compliance FCC Registration Number (FRN): 0033529363 Physical U.S. Company Address: 844 HIGHLAND AVE, NEEDHAM HIGHTS, 2494 9998, P.O BOX 644 Contact Person: Nateev Meidan Agent Email Address: [email protected] The above contact person accepts the obligation for service of process. The applicant accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. A pplicant Signed: Signed: P rinted name: Guy Hadar Title: EVP, Corporate Development and General Counsel Company Name: Eitan Medical Ltd. Date: 12/4/2025 Agent Signed: Signed: P rintedname: Nateev Meidan Title: Owner Company Name: Noa Compliance Date: 12/4/202 5 * the applicant must designate a contact located in the United States for purposes of acting as the applicant’s agent for service of process, regardless of whether the applicant is a domestic or foreign entity. An applicant located in the United States may designate itself as the agent for service of process.

Eitan Medical Ltd. 29 Yad Haruzim St. P.O. Box 8639 Netanya 4250529, lsrael January 09, 2026 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Ref: FCC new Grants for FCC ID: 2A3JW-EM25 Applicant Name: Eitan Medical Ltd. Dear Examiner, The host Sapphire Connect (FCC ID: 2A3JW-EM25) is a new product with one certified module (LTE Cat M1& Cat NB2&EGPRS Module (Module FCC ID:XMR202005BG95M5). Grant date: 08/07/2020) integrated. This module is a single module, which is integrated into the host without any impact on the RF performance. The host (Sapphire Connect) only reserves the LTE&GSM band for this module, and the remaining bands are all software-disabled. Considering that the antenna is designed for the host (Sapphire Connect), we retested the power/ERP/EIRP and RSE when the module is integrated into the host. Test report data clarification Standard Original test reports No.: Testing Data Remark FCC Part15B Report No.: CHTW25100020 N/A Full testing N/A FCC Part 22&24&27 LTE Cat M1 Band 2/ 4/ 5/12 LTE Cat NB2 Band 2/ 4/ 5/12 Report No.: CHTW25100018 CHTW25100019 R2005A0283-R1V1 R2005A0283-R2V1 R2005A0283-R4V1 R2005A0283-R6 R2005A0283-R7 Add full test: ERP/EIRP/Radiated Spurious Emission Based on the module difference description, Frequency Stability, Occupied Bandwidth, Emission Bandwidth, band edge and Conducted Spurious Emission are evaluated refer to original reports FCC Part 22&24 GSM850 PCS1900 Report No.: CHTW25100017 R2005A0283-R1V1 R2005A0283-R2V1 Add full test: ERP/EIRP/Radiated Spurious Emission Based on the module difference description, Frequency Stability, Occupied Bandwidth, Emission Bandwidth, band edge and Conducted Spurious Emission are evaluated refer to original reports FCC Part 2.1093 Report No.: CHTW25100010 N/A Full Evaluate Re-evaluation of individually and simultaneously launched MPEs based on validation and test results CONCLUSION This radio device continues to meet all FCC standard requirements. Please contact me if you have any questions or need further information regarding this application. Eitan Medical Ltd. 29 Yad Haruzim St. P.O. Box 8639 Netanya 4250529, lsrael Sincerely, Signature: Full name of contact person listed on FCC’s website: Guy Hadar Title: EVP, Corporate Development and General Counsel Tel.: +972-544736672 Email: [email protected]

Eitan Medical Ltd. Dec. 15, 25 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Subject: Confidentiality Request for: FCC ID: 2A3JW-EM25 Pursuant to Sections 0.457 and 0.459 of the Commission’s Rules, we hereby request permanent confidential treatment of the exhibits accompanying this certification application as outlined below :  Block Diagram  Schematics  Operational Description  Part List  Tune-up procedure The above exhibits contain trade secrets and/or proprietary information that are not publicly available and materials that the Applicant has spent considerable efforts in developing. Public disclosure of these may be harmful to the Applicant and give an unfair advantage to competitors on the market. Pursuant to DA 04-1705, the applicant also requests temporary confidential treatment of the exhibits outlined below for a period of (up to180)days from the date of equipment authorization and prior to marketing in the United States to prevent the premature release of any sensitive information. Applicant is aware of their responsibility to notify DERYCOMin the event information regarding the product or the product is made available to the public before the requested period has expired.  User Manual  Internal Photos  External Photos  Test Setup Photos Sincerely, Signature: Printed Name: Guy Hadar Title: EVP, Corporate Development and General Counsel Tel.: 054-4736672 Email: [email protected]

Eitan Medical Ltd. December 04, 2025 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 Subject: Agent Authorization for FCC ID: 2A3JW-EM25 I, the undersigned, hereby authorize Global United Technology Services Co., Ltd. to act on our behalfin all matters relating to this application for equipment certification. Any act carried out by Global United Technology Services Co., Ltd. shall have the same effect as our own and I acknowledge that all responsibility for complying with the terms and conditions of certification, as specified by DERYCOM CERTIFICATION SERVICES, INC., still resides with Eitan Medical Ltd. We certify that we are not subject to a denial of federal benefits that includes FCC benefitspursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. §862, and that no partyto the application, as defined in 47 CFR §1.2002(b), is subject to a denial of federal benefits that includes FCC benefits pursuant to that section. Sincerely, Signature: Full name of contact person listed on FCC’s website: Guy Hadar Title: EVP, Corporate Development and General Counsel Tel.: 054-4736672 Email: [email protected]

Label location

53 + 0.400 62 + 0.4 0 6.6 ±0.2 53.6 ±0.2 3.7 ±0.2 4X R1 R0.8 TRANSPARENT AREA NO ADHESIVE NO CUTTING SIGNS 0.275 mm TO 0.330 mm (TOTAL NOMINAL THICKNESS) 3M ADHESIVE TRANSFER TAPE 468MP/9627 (0.13mm thicknes) GE LEXAN 8B35 FILM (TEXTURE MATT; 0.175mm TO 0.200mm NORMAL THICKNESS) NOTES: THIS DRAWING ONLY SPECIFIES THE DIMENSIONS AND MATERIAL OF THE 1. LABEL. DESIGN AND TEXTURE PER ACCOMPANIED GRAPHIC DRAWING2. PRINT ON ADHESIVE SIDE3. THIS DRAWING IS BACKED BY A 3D CAD FILE. WHERE DIMENSIONS ARE 4. NOT NOTED ON DRAWING, THEY SHALL BE TAKEN FROM 3D CAD FILE. PARTS SHOULD BE COMPLIANT WITH ROHS 3, DIRECTIVE (EU) 2015/8635. MATERIAL: GE LEXAN 8B35 0.175mm6. 2 1 PROPRIETARYANDCONFIDENTIAL THEINFORMATIONCONTAINEDINTHISDRAWING ISTHEPROPERTYOFMEDICALLTD. ANY REPRODUCTIONINPARTORASA WHOLE WITHOUTTHEWRITTENPERMISSIONO FTHE COMPANYISPROHIBITED. EITAN 2025 Eitan Medical Ltd. DESCRIPTIONDATEREV 01 INITIAL DRAFT NOT FOR PRODUCTION ECO NO/ MP SYSTEM 09.SEP.2021 SapphireConnect -M6 GTIN: (01) 7290109154305 15044-003-1032 Rev. 02 TRANSPARENT AREA C: M: Y: K: R: G: B: PANTONE: c dc C=0 M=0 Y=o K=100 FOR MECHANICAL DATA SHEET SEE PAGE #1 1. DURABILITY TEST: ACCORDING TO IEC 60601-1 2. PRINT SCALE 1:1 3.DYNAMIC LABEL P/N: 15044-003-1060-LBL NOTE FCC ID: 2A3JW-EM25 IC: 27442-EM25; HVIN: 02 CAN ICES-003 (B) /NMB-003 (B) HVIN 02 FVIN 16.0.0 IP24 Sapphire™ Connect REF 15044-000-1029 DC 10V/1.5A DC 5V/2.75A 10V 2025 Eitan Medical Ltd. PROPRIETARY AND CONFIDENTIAL THE INFORMATION CONTAINED IN THIS DRAWING IS THE PROPERTY OFMEDICAL LTD. ANY REPRODUCTION IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION O FTHE COMPANY IS PROHIBITED. EITAN 02 Changed FCC ID, IC ID 28.MAY.2025 SC - HW & Antenna

TEST REPORT For EMC Report No......................................... : CHTW25100020 Project No ........................................ : SHT2506047205W Applicant’s name ............................. : Eitan Medical Ltd. Address ............................................ : 29 Yad Haruzim St. P.O. Box 8639 Netanya 4250529, Israel Product Name .................................. : Sapphire Connect Trade Mark....................................... : Eitan Medical Model No.......................................... : 15044-000-1029 Listed Model(s) ................................ : - Standard .......................................... : FCC CFR Title 47 Part 15 Subpart B Date of receipt of test sample..........: 2025/6/20 Date of testing.............................: 2025/7/9- 2025/7/15 Date of issue...............................: 2025/10/11 Result ................... ........................: PASS Compiled by (Position+Printed name+Signature) : File administrator Caspar Chen Supervised by (Position+Printed name+Signature) : Project Engineer Xiaodong Zhao Approved by (Position+Printed name+Signature) : RF Manager Xu Yang Testing Laboratory Name ............. : Shenzhen Huatongwei International Inspection Co., Ltd. Address ............................................ : Building 7, Baiwang Idea Factory, No.1051, Songbai Road, Yangguang Community, Xili Subdistrict, Nanshan District, Shenzhen, Guangdong, China Test Report Form No. ........................ : R0066 Test Report Form(s) Originator ......... : Shenzhen Huatongwei International Inspection Co., Ltd. Master TRF ........................................ : Dated 2025-07 Shenzhen Huatongwei International Inspection Co., Ltd. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the Shenzhen Huatongwei International Inspection Co., Ltd. is acknowledged as copyright owner and source of the material. Shenzhen Huatongwei International Inspection Co., Ltd. takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context.The test report merely correspond to the test sample.The authenticity of this Test Report and its contents can be verified by contacting the Laboratory, responsible for this Test Report. Report No.: CHTW25100020 Page 2 of 23 Contents 1. TEST STANDARDS AND REPORT VERSION ........................................... 3 1.1. Test Standards 3 1.2. Report version information 3 2. TEST DESCRIPTION .................................................................... 4 3. SUMMARY ............................................................................... 5 3.1. Client Information 5 3.2. Product Description 5 3.3. Testing Laboratory Information 5 4. TEST CONFIGURATION ................................................................. 6 4.1. Descriptions of test mode 6 4.2. Configuration of Tested System 6 4.3. Support unit used in test configuration 7 4.4. Environmental conditions 7 4.5. Statement of the measurement uncertainty 7 4.6. Equipments Used during the Test 8 5. TEST CONDITIONS AND RESULTS ..................................................... 9 5.1. Conducted Emissions 9 5.2. Radiated Emissions 11 6. TEST SETUP PHOTOS OF THE EUT .................................................. 15 7. EXTERNAL AND INTERNAL PHOTOS OF THE EUT .................................. 16 7.1. External photos 16 7.2. Internal photos 19 Report No.: CHTW25100020 Page 3 of 23 1. TEST STANDARDS AND REPORT VERSION 1.1. Test Standards The tests were performed according to following standards: FCC CFR Title 47 Part 15 Subpart B - Unintentional Radiators ANSI C63.4: 2014 – American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40GHz 1.2. Report version information Revision No. Date of issue Description N/A 2025-10-11 Original Report No.: CHTW25100020 Page 4 of 23 2. TEST DESCRIPTION Section Test Item Section in CFR 47 Result #1 Test Engineer 5.1 Conducted Emissions 15.107(a) PASS YATING.CHEN 5.2 Radiated Emissions 15.109(a) PASS CHUANFENG.LI YIFAN.WANG Note: #1: The test result does not include measurement uncertainty value Report No.: CHTW25100020 Page 5 of 23 3. SUMMARY 3.1. Client Information Applicant: Eitan Medical Ltd. Address: 29 Yad Haruzim St. P.O. Box 8639 Netanya 4250529, Israel Manufacturer: Eitan Medical Ltd. Address: 29 Yad Haruzim St. P.O. Box 8639 Netanya 4250529, Israel 3.2. Product Description Main unit information: Product Name: Sapphire Connect Trade Mark: Eitan Medical Model No.: 15044-000-1029 Listed Model(s): - Power supply: DC 3.7V from Battery Hardware version: 2.2 Software version: 2.0.0 Accessory unit information: Battery information: LiPo Battery FT503450P 3.7V 900mAh Adapter information: Model: FW8000M/05 Input: 100-240V~/50-60Hz/300-150mAh Output: 5Vd.c./2200mA 3.3. Testing Laboratory Information Laboratory Name Shenzhen Huatongwei International Inspection Co., Ltd. Laboratory Location Building 7, Baiwang Idea Factory, No.1051, Songbai Road, Yangguang Community, Xili Subdistrict, Nanshan District, Shenzhen, Guangdong, China Connect information: Tel: 400-963-0755 E-mail: [email protected] http://www.szhtw.com.cn Qualifications Type Accreditation Number FCC Registration Number 762235 FCC Designation Number CN1181 Report No.: CHTW25100020 Page 6 of 23 4. TEST CONFIGURATION 4.1. Descriptions of test mode Test mode Description TM1 Keep the device in power on and active mode. Test Item Test mode Conducted Emissions TM1 Radiated Emissions TM1 4.2. Configuration of Tested System Test mode Configuration TM1 Report No.: CHTW25100020 Page 7 of 23 4.3. Support unit used in test configuration The EUT has been associated with peripherals and configuration operated in a manner tended to maximize its emission characteristics in a typical application. The following peripheral devices …

Text truncated - open the document above for the full version.