MAXIM KNEE SYSTEM

FDA UDI

Biomet Orthopedics, LLC·00880304234536·

VANGUARD(TM) MICROPLASTY(R)

FDA UDI

Biomet Orthopedics, LLC·00880304349728·

Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List A ·Sanway Gene Tech. Inc.·1 device

GB19/964430

Certificate

MDD Annex II (excluding section 4)·BPR Medical Limited·SGS Belgium NV·44 Basic UDI-DIs

HU24/00000124

Certificate

MDR QMS·Distalmotion Ltd·SGS Belgium NV

V7 060578 0017

Certificate

IVDD Annex IV Section 4·InTec PRODUCTS, INC.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

V7 060578 0022

Certificate

IVDD Annex IV Section 4·InTec PRODUCTS, INC.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs

V7 060578 0017

Certificate

IVDD Annex IV Section 4·InTec PRODUCTS, INC.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

V7 060578 0022

Certificate

IVDD Annex IV Section 4·InTec PRODUCTS, INC.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

V1 061788 0008

Certificate

IVDD Annex IV (excluding sections 4, 6)·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

No. V1 061788 0008

Certificate

IVDD Annex IV (excluding sections 4, 6)·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

44232117836

Certificate

MDD Annex II (excluding section 4)·Yelatma Instrument-Making Enterprise Joint-Stock Company·TÜV NORD CERT GmbH·6 Basic UDI-DIs

QPZ-01910-18

Certificate

MDD Annex V·MDT Int'l SA·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI

QCT-0176-21

Certificate

MDD Annex II (excluding section 4)·MDT Int'l SA·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI

2116232DE01

Certificate

MDD Annex II Section 4·MDT Int'l SA·DEKRA Certification B.V.·3 Basic UDI-DIs

2116232DE02

Certificate

MDD Annex II Section 4·MDT Int'l SA·DEKRA Certification B.V.·2 Basic UDI-DIs

CeCert/037/W/E.1

Certificate

IVDD Annex III Section 6·Merlin Biomedical (Xiamen) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI

716015

Certificate

IVDD Annex IV Section 4·Atomo Diagnostics Limited·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

637070

Certificate

IVDD Annex IV (excluding sections 4, 6)·Atomo Diagnostics Limited·BSI Group The Netherlands B.V.·2 Basic UDI-DIs

MedicloseTM System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology