Eu Ivdd Eu Ivd Self Testing On The Market 🇩🇪 Germany

Fortel Ulcer (H. pylori) Screening Test

BIOEUROPE GmbH · 🇩🇪 Germany
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1

Basic Information

Primary DI
D-1005-1KN
Basic UDI-DI Code
B-1005-1KN
Reference
1005-1
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd Self Testing
Status
On The Market
Manufacturer
BIOEUROPE GmbH

Additional Description

Rapid test for the detection of the presence of Helicobacter pylori antibodies in whole blood.

CND Nomenclature Codes

Code Description
W0105090102 H. PYLORI - RT & POC

Certificates

Type Number
IVDD Annex IV (excluding sections 4, 6) 22823

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