4,010 results · 44ms · Sources: EU EUDAMED, US FDA

t2 prosthesis

Basic UDI-DI
EU MDD · Eu Md Class 1 ·trackinvention eK·1 device

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex

Diagnostic Low Electric Field

FDA Pre-Market Approval
FDA Class 3 ·DUNE MEDICAL DEVICES MARGINPROBE SYSTEM

Medical Monitor

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Xuzhou AKX Electronic Science and Technology co.,Ltd·1 device

Digital Electronic Colposcope

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Xuzhou AKX Electronic Science and Technology co.,Ltd·2 devices

Endoscope Camera (FULL HD Endoscope System; 4K Medical Endoscope Camera System)

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Xuzhou AKX Electronic Science and Technology co.,Ltd·13 devices

GUM®

FDA UDI
SUNSTAR AMERICAS, INC.·00070942302722·ORAL CARE CLEANING KIT

Meijer

FDA UDI
MEIJER, INC.·00713733815628·Dental Tools

I-pak

FDA UDI
APPLIED DENTAL, INC.·00814639020694·Sterile Dental I-pak (Intraoral Exam pack) with...

CareOne

FDA UDI
Ahold U.S.A., Inc.·00041520021250·Dental Tools

C-01-1189-729-20

Certificate
MDD Annex II (excluding section 4)·Eko Health, Inc.·Eurofins Electric & Electronics Finland Oy·2 Basic UDI-DIs

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS™) Lung System

Hangzhou Singclean Medical Products Co., Ltd.

Manufacturer
🇨🇳 China·149 Basic UDI-DIs·149 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·S670 WITH D OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS, S660 WITH DISCRETE TECH OVER-THE-WIRE AND RAPID EXS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·TVL(TM) LEAD SYSTEM

HCV ANTIBODY -RT & POC

Device
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

HBSAG - RT & POC

Device
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

Singfiller

Device
EU MDD · Eu Md Class 3 ·Hangzhou Singclean Medical Products Co., Ltd.·On the market·4 countries

Singfiller

Device
EU MDD · Eu Md Class 3 ·Hangzhou Singclean Medical Products Co., Ltd.·On the market·4 countries

Singfiller

Device
EU MDD · Eu Md Class 3 ·Hangzhou Singclean Medical Products Co., Ltd.·On the market·4 countries