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AiDTM HBsAg ELISA
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref WB-1296Ref WB-12480
Identity
- Device Name
- AiDTM HBsAg ELISA EUDAMED
- Model / Reference
- WB-1296 EUDAMEDWB-12480 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970301452461 EUDAMED06970301452478 EUDAMED
- Basic UDI-DI
- B-06970301452461 EUDAMEDB-06970301452478 EUDAMED
- EMDN Code
- W0105020201 HEPATITIS B SURFACE ANTIGEN EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Hungary 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
AiDTM HBsAg ELISA by Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. — Class IVD Annex II List A — IVDD — listed in EUDAMED
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-06970301452461 | Class IVD Annex II List A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000040626
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED f07a2dad-83d9-4c75-bf89-c447280a2a8d 61 fields · synced Jul 12, 2026
- EUDAMED f71cee98-5edc-4941-8acd-21b2a231209e 61 fields · synced May 18, 2026