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HAV IgM Rapid Test
EUDAMEDClass B (EU MDR)
Ref A40310Model A40310125, A40310140, A40310225, A40310240
Identity
- Trade Name
- HAV IgM Rapid Test EUDAMED
- Device Name
- HAV IgM Rapid Test EUDAMED
- Model / Reference
- A40310125, A40310140, A40310225, A40310240 EUDAMEDA40310 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804831998 EUDAMED
- Basic UDI-DI
- 69528048A403100XP EUDAMED
- EMDN Code
- W0105020104 HAV ANTIBODY IGM EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
HAV IgM Rapid Test by Assure Tech. (hangzhou) Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69528048A403100XP | Class B | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 1bc2ca1e-7f1d-43d6-8694-23011e440a9a 61 fields · synced Jun 19, 2026