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Ovu Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref ACK21003-S05-011Model Strip
Identity
- Trade Name
- OVU TEST EUDAMED
- Device Name
- LH Ovulation Tests EUDAMED
- Model / Reference
- Strip EUDAMEDACK21003-S05-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942468134573 EUDAMED
- Basic UDI-DI
- B-06942468134573 EUDAMED
- EMDN Code
- W0102160304 LH - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Ovu Test by Core Technology Co., Ltd. — Class IVD devices for self-testing — 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-06942468134573 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Core Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023522
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 381e893c-9c59-42a7-997c-564f7e6f5198 61 fields · synced Jul 8, 2026