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Meriscreen
EUDAMEDClass D (EU MDR)
Ref HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 , 08, 09, 10, 11, 12Model HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 HVWRPD-08 HVWRPD-09 HVWRPD-10 HVWRPD-11 HVWRPD-12
Identity
- Trade Name
- MERISCREEN EUDAMED
- Device Name
- MERISCREEN HIV 1-2 WB EUDAMED
- Model / Reference
- HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 HVWRPD-08 HVWRPD-09 HVWRPD-10 HVWRPD-11 HVWRPD-12 EUDAMEDHVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 , 08, 09, 10, 11, 12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18906074564327 EUDAMED
- Basic UDI-DI
- 8905459MHVWRPDJX EUDAMED
- Direct Marketing DI
- 18906074564327 EUDAMED
- EMDN Code
- W0105090302 HIV 1 / 2 - RT & POC EUDAMED
Classification
- Device Class
- Class D EUDAMED
- Market of Registration
- Netherlands 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
Yes
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 | 8905459MHVWRPDJX | 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 (2)
- EUDAMED e04257f6-0c47-408f-a687-579cdcd71335-1 61 fields · synced Jul 9, 2026
- EUDAMED e04257f6-0c47-408f-a687-579cdcd71335-2 61 fields · synced Jul 9, 2026