402 results · 31ms · Sources: EU EUDAMED, US FDA

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Laboratoire CAT

Manufacturer
🇫🇷 France

BIT Group France

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

BIT Group France

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

ESP Mask

Device
EU MDR · Eu Md Class 1 ·SIMON ET CIE·On the market

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

ESP mask

Basic UDI-DI
EU MDR · Eu Md Class 1 ·SIMON ET CIE·1 device

CDT SAMPLES TREATMENT SOLUTION

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·sebia·1 device

Orthopaedic implant drill bits, single use

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

ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003

FDA Enforcement
Class II ·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023

ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009

FDA Enforcement
Class II ·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023

CIR MEDICAL

System producer
🇫🇷 France

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

HZ 1457263-1

Certificate
MDR QMS·CUTTING EDGE SAS·TÜV Rheinland LGA Products GmbH

CAPILLARYS 3 & MC SWITCH RACK FOR CDT (1)

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·sebia·1 device

EUROPEAN MARCO POLO COMPANY

Importer
🇫🇷 France·6 Manufacturers

FibroMax

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

COMED SAS

Importer
🇫🇷 France·25 Manufacturers

DECOCENT

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·DIAGNOTIS SAS·1 device

MYCOPROSAFE

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·DIAGNOTIS SAS·1 device