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Meriscreen
EUDAMEDClass D (EU MDR)
Ref RPDHBV-01 RPDHBV-03Model RPDHBV-01 RPDHBV-03
Identity
- Trade Name
- MERISCREEN EUDAMED
- Device Name
- MERISCREEN HBsAg EUDAMED
- Model / Reference
- RPDHBV-01 RPDHBV-03 EUDAMEDRPDHBV-01 RPDHBV-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18906074563603 EUDAMED
- Basic UDI-DI
- 8905459MHBSAGRTG4 EUDAMED
- Direct Marketing DI
- 18906074563603 EUDAMED
- EMDN Code
- W0105020201 HEPATITIS B SURFACE ANTIGEN EUDAMED
Classification
- Device Class
- Class D EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Meriscreen by Meril Diagnostics Pvt. Ltd. — Class D — 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 | 8905459MHBSAGRTG4 | Class D | Active |
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Manufacturer
- Manufacturer
- Meril Diagnostics Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000028158
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED dd0ca46e-9f73-4c46-96e1-d72e9ab2b0df 61 fields · synced Aug 3, 2026