Identity
- Trade Name
- HBV RealQuant™ PCR EUDAMED
- Device Name
- HBV RealQuant™ PCR EUDAMED
- Model / Reference
- 4HBPA2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712803530016 EUDAMED
- Basic UDI-DI
- B-04712803530016 EUDAMED
- EMDN Code
- W0105020299 HBV REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
HBV RealQuant™ PCR by General Biologicals Corporation — Class IVD Annex II List A — 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-04712803530016 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- General Biologicals Corporation
- EUDAMED SRN
- TW-MF-000024694
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 1a176949-c4e8-432e-a9ef-14cdefd9f5f0 61 fields · synced Jul 9, 2026