EU Quality Management System Certificate Regulation (EU) 2017/745, Annex IX Chapter I and III MDR 799807 R000 MDR 799807 R000 Manufacturer: Neo Modulus (Shandong) Medical Sci-Tech Co., Ltd. Address: No. 88 Xinlong Road Fengjia Community Xinchang Street High-Tech Zone Weifang Shandong 261061 China Single Registration Number: CN-MF-000038528 EU Authorised Representative: MedPath GmbH Address: Mies-van-der-Rohe-Strasse 8 80807 Munich Germany Scope: See attached Device Schedule On the basis of our examination of the quality system in accordance with Regulation (EU) 2017/745, Annex IX Chapter I and III, the quality system meets the requirements of the Regulation. For the placing on the market of Class III devices, and Class IIb implantable devices that are not considered well-established technologies as specified in Article 52(4) an additional Annex IX Chapter II certificate is required. For and on behalf of BSI, a Notified Body for the above Regulation (Notified Body Number 2797): Graeme Tunbridge, Senior Vice President Global Regulatory & Quality First First Issue Issue Date: Date: 2024-07-02 2024-07-02 Starting Starting Validity Validity Date: Date: 2024-07-02 2024-07-02 Current Current Issue Issue Date: Date: 2024-07-02 2024-07-02 Expiry Expiry Date: Date: 2029-07-01 2029-07-01 Page 1 of 3 Validity of this certificate is conditional on the Manufacturer’s quality system being maintained to the requirements of the Regulation as demonstrated through the required surveillance activities of the Notified Body. This certificate was issued electronically and is bound by the conditions of the contract. NB Contact: BSI Group The Netherlands B.V., Say Building, John M. Keynesplein 9, 1066 EP, Amsterdam, Netherlands. Tel: + 31 (0) 20 346 07 80 Corporate Contact: BSI Group Assurance Limited, registered in England under number 05435540 at 389 Chiswick High Road, London, W4 4AL, UK. A Member of the BSI Group of Companies.

EU Quality Management System Certificate Regulation (EU) 2017/745, Annex IX Chapter I and III Device Schedule: Class IIa, Custom-made and other devices Device(s) Risk Classification Nasal Hemostasis Sponge Class Is For Class Is devices, the Notified Body conformity assessment is limited to the aspects relating to establishing, securing and maintaining sterile conditions. First Issue Date: 2024-07-02 Starting Validity Date: 2024-07-02 Current Issue Date: 2024-07-02 Page 2 of 3 Validity of this certificate is conditional on the Manufacturer’s quality system being maintained to the requirements...

EU Quality Management System Certificate Regulation (EU) 2017/745, Annex IX Chapter I and III Certificate History (References to applicable Common Specifications, Harmonized Standards complied with, and the relevant test and audit reports that support any of the below certificate changes may be requested from [email protected]) Date Current Action Issued First Issue Date: 2024-07-02 Starting Validity Date: 2024-07-02 Current Issue Date: 2024-07-02 Page 3 of 3 Validity of this certificate is conditional on the Manufacturer’s quality system being maintained to the requirements...