Identity
- Trade Name
- ANTISURASE B-96 II (TMB) EUDAMED
- Device Name
- ANTISURASE B-96 II (TMB) EUDAMED
- Model / Reference
- 4SBE6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712803532256 EUDAMED
- Basic UDI-DI
- B-04712803532256 EUDAMED
- EMDN Code
- W0105020203 HEPATITIS B SURFACE ANTIBODY (TOTAL) EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Antisurase B-96 Ii (tmb) 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-04712803532256 | 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 be5b9d9f-fbc6-4ea4-bbab-29595fb98db4 61 fields · synced Jul 15, 2026