Anti-Factor Xa Activity Test System, Apixaban

FDA classification

FDA Class 2 ·Anti-Factor Xa Activity Test System, Apixaban

GEM SRL

Manufacturer

🇮🇹 Italy·28 Basic UDI-DIs·38 Devices·TUV Rheinland Italia SRL, ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and TUV Rheinland Italia SRL

Uric acid monitoring system

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·General Life Biotechnology Co., Ltd.·1 device

Analyzer, Gas, Water Vapor, Gaseous-Phase

FDA classification

FDA Class 1 ·Analyzer, Gas, Water Vapor, Gaseous-Phase

Selector, Size, Ostomy

FDA classification

FDA Class 1 ·Selector, Size, Ostomy

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·SAHARA CLINICAL BONE SONOMETER

ITD 2406494 1

Certificate

MDR QA·AUTEL S.r.l.·TUV Rheinland Italia SRL

ITD 1344523 1

Certificate

MDR QA·Dispotech srl·TUV Rheinland Italia SRL

DZ 2111577-1

Certificate

MDR QA·SHAOXING YIBON MEDICAL CO., LTD.·TÜV Rheinland LGA Products GmbH

CN24/00002692

Certificate

MDR QA·APT Medical Inc.·SGS Belgium NV

1434-MDR-023/2024

Certificate

MDR QA·Maximus s.c. Robert Klejdysz, Alicja Daniecka-Klejdysz·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

DZ 2081569-1

Certificate

MDR QA·CYBERDYNE Inc.·TÜV Rheinland LGA Products GmbH

DZ 2158445-1

Certificate

MDR QA·OLYMPUS MEDICAL SYSTEMS CORP.·TÜV Rheinland LGA Products GmbH

IT335698

Certificate

MDR QA·WORK IN PROGRESS BIO-MEDICAL S.R.L.·BUREAU VERITAS ITALIA S.P.A.

CN24/00006623

Certificate

MDR QA·Dongguan Senmed Medical Instrument Co., Ltd.·SGS Belgium NV

DZ 2250336-1

Certificate

MDR QA·Shenzhen KangDaAn Biological Technology co., Ltd·TÜV Rheinland LGA Products GmbH

M.2024.MDR1054

Certificate

MDR QA·DİSPACK TIBBİ SAN. TİC. LTD. ŞTİ.·UDEM Adriatic d.o.o.

M.2024.MDR.1053

Certificate

MDR QA·ERMED TIP MEDİKAL TİCARET A.Ş.·UDEM Adriatic d.o.o.

ITD 2423536 1

Certificate

MDR QA·Sidam S.R.L.·TUV Rheinland Italia SRL

ITD 1343612 1

Certificate

MDR QA·Dompé farmaceutici s.p.a.·TUV Rheinland Italia SRL