406 results · 21ms · 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.

BIT Group France

FDA registration
BIT Group France·1 product·🇫🇷 France

BIT Group France

FDA registration
BIT Group France·1 product·🇫🇷 France

HEAD IMPACTOR BIT

Device
EU MDR · Eu Md Class 1 ·groupe lépine·On the market

HEAD IMPACTOR BIT

Device
EU MDR · Eu Md Class 1 ·groupe lépine·On the market

GAMIDA TECH

Manufacturer
🇫🇷 France·4 Basic UDI-DIs·4 Devices·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

Kaio-Dia

Importer
🇫🇷 France·1 Manufacturer

Orthopaedic implant drill bits, single use

Basic UDI-DI
EU MDR · Eu Md Class 2a ·groupe lépine·4 devices

Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery.

FDA Enforcement
Class II ·Terminated·NEOSTEO·August 18, 2021

IT267632 - 1

Certificate
MDD Annex II (excluding section 4)·DIS PAR·BUREAU VERITAS ITALIA S.P.A.·1 Basic UDI-DI

Kaio-Dia

Authorized representative
🇫🇷 France·1 Manufacturer·2023 Devices

MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA INSTRUMENTS - CONSUMABLES

Device
EU MDD · Eu Md Class 2b ·GAMIDA TECH·No longer on the market·10 countries

MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA INSTRUMENTS - CONSUMABLES

Device
EU MDD · Eu Md Class 2b ·GAMIDA TECH·On the market·11 countries

MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT

Device
EU MDD · Eu Md Class 2b ·GAMIDA TECH·On the market·8 countries

CE 663351

Certificate
MDD Annex II (excluding section 4)·EDL (Edition et Développement de Logiciels)·BSI Group The Netherlands B.V.·1 Basic UDI-DI

CE663351

Certificate
MDD Annex II (excluding section 4)·EDL (Edition et Développement de Logiciels)·BSI Group The Netherlands B.V.·1 Basic UDI-DI

Set SunChip1 ouvert

Basic UDI-DI
EU MDD · Eu Md Class 2b ·GAMIDA TECH·1 device

Set SunChip 2

Basic UDI-DI
EU MDD · Eu Md Class 2b ·GAMIDA TECH·1 device

SunChip2

Basic UDI-DI
EU MDD · Eu Md Class 2b ·GAMIDA TECH·1 device

FibroMax

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biopredictive·1 device

1850/MDD

Certificate
MDD Annex II (excluding section 4)·GAMIDA TECH·IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.·3 Basic UDI-DIs