4,135 results
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45ms
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Sources: EU EUDAMED, US FDA
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
FDA 510(k)
FDA Class 2
·Neurology
CARESCAPE B650
FDA 510(k)
FDA Class 2
·Cardiovascular
PLANMECA PROMAX 3D MID
FDA 510(k)
FDA Class 2
·Dental
CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
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
170222 QS/NB
Certificate
MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI
Xpert® Nasal Sample Collection Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Cepheid·1 device
MGI Tech GmbH
Importer
🇩🇪 Germany·3 Manufacturers
Inherited Metabolic Sample (Liquid Chromatography-Tandem Mass Spectrometry) Pretreatment System
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BGI EUROPE A/S·1 device
Liquid Chromatography Tandem Mass Spectrometer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BGI EUROPE A/S·1 device
Nucleic Acid Extraction Kit Pro
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BGI EUROPE A/S·1 device
Hand-held Nucleic Acid Detection Analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BGI EUROPE A/S·1 device
Nucleic Acid Extraction Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BGI EUROPE A/S·1 device
Nucleic Acid Extraction Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BGI EUROPE A/S·2 devices
Incubator
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BGI EUROPE A/S·1 device
Sample Releasing Agent
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BGI EUROPE A/S·1 device
sequencing system
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BGI EUROPE A/S·1 device
Stool Sample Collection Kit for Colorectal Cancer Testing
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BGI EUROPE A/S·1 device
Sample Pretreatment Kit for Methylation Detection
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·BGI EUROPE A/S·2 devices