Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇩🇪 Germany
Fortel Prostate (PSA) Screening Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-1081-1LS
- Basic UDI-DI Code
- B-1081-1LS
- Reference
- 1081-1
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- BIOEUROPE GmbH
Additional Description
Rapid test for the determination of human Prostate Specific Antigen (PSA) in whole blood.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160202 | PSA - RT & POC |
Certificates
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