4,727 results
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45ms
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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