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OvuFind
EUDAMEDClass B (EU MDR)
Ref OVFRPD-01 OVFRPD-02Model OVFRPD-01 OVFRPD-02
Identity
- Trade Name
- OvuFind EUDAMED
- Device Name
- OvuFind™ Ovulation Rapid Test EUDAMED
- Model / Reference
- OVFRPD-01 OVFRPD-02 EUDAMEDOVFRPD-01 OVFRPD-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08905459006721 EUDAMED
- Basic UDI-DI
- 8905459OVULHRDTSFA5 EUDAMED
- Direct Marketing DI
- 08905459006721 EUDAMED
- EMDN Code
- W0102160304 LH - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
OvuFind by Meril Diagnostics Pvt. 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 | 8905459OVULHRDTSFA5 | Class B | 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 4614ad7b-5eb7-46ed-af7a-c3dc697723fc 61 fields · synced Jun 18, 2026