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Prueba Rápida de HBsAg en Casete
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref IHBSG-402
Identity
- Trade Name
- Prueba Rápida de HBsAg en Casete EUDAMED
- Device Name
- Prueba Rápida de HBsAg en Casete EUDAMED
- Model / Reference
- IHBSG-402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436592551378 EUDAMED
- Basic UDI-DI
- B-08436592551378 EUDAMED
- EMDN Code
- W0105090201 HBSAG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Prueba Rápida de HBsAg en Casete by Hangzhou Alltest Biotech.Co., Ltd. — 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-08436592551378 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 9dd66878-7629-4043-993d-2ed228423867 61 fields · synced Jun 14, 2026