Identity
- Trade Name
- SURASE B-96 (TMB) EUDAMED
- Device Name
- SURASE B-96 (TMB) EUDAMED
- Model / Reference
- 4SGE3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04712803531136 EUDAMED
- Basic UDI-DI
- B-04712803531136 EUDAMED
- EMDN Code
- W0105020201 HEPATITIS B SURFACE ANTIGEN 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
No
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
Surase B-96 (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-04712803531136 | 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 642b3b19-c406-4e7a-9b0f-dbdf16cbbab7 61 fields · synced Jun 18, 2026