Identity
- Device Name
- Exdia β-hCG EUDAMED
- Model / Reference
- PR-FC10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800026300106 EUDAMED
- Basic UDI-DI
- B-08800026300106 EUDAMED
- EMDN Code
- W0102050206 B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Exdia β-hCG by Precision Biosensor Inc. — Class IVD General — 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-08800026300106 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Precision Biosensor Inc.
- EUDAMED SRN
- KR-MF-000034861
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 63229fc9-7b52-4cb9-a7ca-93d6439a4b3a 61 fields · synced Sep 17, 2026