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Fortel® Prostate (PSA) Screening Test
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 1081-1
Identity
- Trade Name
- Fortel® Prostate (PSA) Screening Test EUDAMED
- Device Name
- Fortel Prostate (PSA) Screening Test EUDAMED
- Model / Reference
- 1081-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00083059108118 EUDAMED
- Basic UDI-DI
- B-00083059108118 EUDAMED
- EMDN Code
- W0102160202 PSA - RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Fortel® Prostate (PSA) Screening Test by Biomerica, Inc. — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00083059108118 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Biomerica, Inc.
- EUDAMED SRN
- US-MF-000015772
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 41dbccb0-2bfb-422f-9936-bf3e2c9a5097 61 fields · synced Sep 17, 2026