4,135 results · 45ms · 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