1,486 results · 9ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

FIC-CMFD

Basic UDI-DI
EU IVDD · Eu Ivd General ·NanoEntek, Inc.·1 device

HZ 2093717-1

Certificate
MDR QMS·J. MORITA MFG. CORP.·TÜV Rheinland LGA Products GmbH

Broadsound Corporation

Manufacturer
🇹🇼 Taiwan·26 Basic UDI-DIs·26 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

SB-KAWASUMI LABORATORIES, INC.

Manufacturer
🇯🇵 Japan·408 Basic UDI-DIs·426 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Assut Medical Sàrl

Manufacturer
🇨🇭 Switzerland·2 Basic UDI-DIs·2 Devices·2 Importers·DEKRA Certification B.V. and DEKRA Certification B.V.

BIOLASE MG LLC

Manufacturer
🇺🇸 United States·185 Basic UDI-DIs·185 Devices·DNV MEDCERT GmbH and DNV MEDCERT GmbH

SOOIL Development Co., Ltd.

Manufacturer
🇰🇷 South Korea·56 Basic UDI-DIs·56 Devices·4 Importers·SGS Belgium NV and SGS Belgium NV

Scientia Vascular, Inc.

Manufacturer
🇺🇸 United States·6 Basic UDI-DIs·6 Devices·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

Biomech Innovations AG

Manufacturer
🇨🇭 Switzerland·2 Basic UDI-DIs·2 Devices·ITALCERT SRL and ITALCERT SRL

Hanalytics Pte Ltd

Manufacturer
🇸🇬 Singapore·1 Basic UDI-DI·1 Device·TÜV Rheinland LGA Products GmbH

Soteria Biotech Co., Ltd.

Manufacturer
🇹🇼 Taiwan·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH

Turner Imaging Systems, Inc.

Manufacturer
🇺🇸 United States·1 Basic UDI-DI·1 Device·BSI Group The Netherlands B.V.

Advanced Ophthalmic Innovations Pte. Ltd.

Manufacturer
🇸🇬 Singapore·1 Basic UDI-DI·1 Device·4 Importers·TÜV Rheinland LGA Products GmbH

Ziosoft, Inc.

Manufacturer
🇯🇵 Japan·1 Basic UDI-DI·1 Device·TÜV Rheinland LGA Products GmbH

Pulsenmore Ltd

Manufacturer
🇮🇱 Israel·2 Basic UDI-DIs·2 Devices·2 Importers·MTIC InterCert S.r.l.

Radiant Innovation Inc.

Manufacturer
🇹🇼 Taiwan·19 Basic UDI-DIs·47 Devices·1 Importer·SGS Belgium NV and SGS Belgium NV

SG Medical Inc.

Manufacturer
🇰🇷 South Korea·57 Basic UDI-DIs·57 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

2194636DE03

Certificate
MDD Annex II Section 4·Assut Medical Sàrl·DEKRA Certification B.V.·1 Basic UDI-DI

474064

Certificate
MDD Annex II (excluding section 4)·Scientia Vascular, Inc.·DQS Medizinprodukte GmbH·5 Basic UDI-DIs

0068/QCO-DM/166-2020

Certificate
MDD Annex II (excluding section 4)·Pulsenmore Ltd·MTIC InterCert S.r.l.·2 Basic UDI-DIs