4,727 results · 42ms · Sources: EU EUDAMED, US FDA

Test For Periprosthetic Joint Infection

FDA classification
FDA Not Classified ·Test For Periprosthetic Joint Infection

HGI Europe Oy

Importer
🇫🇮 Finland·2 Manufacturers

CR-03-1156-859-24

Certificate
MDR QMS·CGI Suomi Oy·Eurofins Electric & Electronics Finland Oy

C-01-1156-735-20

Certificate
MDD Annex II (excluding section 4)·CGI Suomi Oy·Eurofins Electric & Electronics Finland Oy·2 Basic UDI-DIs

Latvia MGI Tech SIA

Authorized representative
🇱🇻 Latvia·1 Manufacturer

NON-STERILE PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

colonic FTRD Set

FDA UDI
Ovesco Endoscopy AG·04260206311010·The colonic FTRD Set is a novel tool for diagno...

FTRD System Set

FDA UDI
Ovesco Endoscopy AG·04260206310556·The FTRD System Set is a novel tool for diagnos...

diagnostic FTRD Set

FDA UDI
Ovesco Endoscopy AG·04260206311072·The diagnostic FTRD Set is a novel tool for dia...

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA classification
FDA Class 3 ·Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

1434-IVDD-011/2022

Certificate
IVDD Annex III Section 6·BGI EUROPE A/S·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

MGI Tech FR, SARL

Importer
🇫🇷 France

Time-of-Flight Mass Spectrometer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Wuhan BGI Biomedical Engineering Co., Ltd.·1 device

Automatic Chemiluminescence Immunoassay Analyzer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Wuhan BGI Biomedical Engineering Co., Ltd.·1 device

Automatic Chemiluminescence Immunoassay Analyzer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Wuhan BGI Biomedical Engineering Co., Ltd.·1 device

System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

FDA classification
FDA Class 2 ·System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·ACTIVA RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM

IMMCO DIAGNOSTICS

FDA UDI
IMMCO DIAGNOSTICS, INC.·00845714004247·WASH BUFFER

Radioimmunoassay, Estriol

FDA classification
FDA Class 1 ·Radioimmunoassay, Estriol

Breast Milk, Rhodamine, Antigen, Antiserum, Control

FDA classification
FDA Class 1 ·Breast Milk, Rhodamine, Antigen, Antiserum, Control