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One Step Ovulation Urine Test
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref W2-MRef W2-C
Identity
- Device Name
- One Step Ovulation Urine Test EUDAMED
- Model / Reference
- W2-M EUDAMEDW2-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-W2-MK2 EUDAMEDD-W2-CJE EUDAMED
- Basic UDI-DI
- B-W2-MK2 EUDAMEDB-W2-CJE EUDAMED
- EMDN Code
- W0102160304 LH - RT & POC EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
One Step Ovulation Urine Test by Guangzhou Wondfo Biotech Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED
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-W2-MK2 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000000689
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 6dcd2456-8d71-4e56-bcf7-47d362fe82a9 61 fields · synced Sep 17, 2026
- EUDAMED 8e4f49e0-7808-40f3-a3fa-e1e0b1409a46 61 fields · synced May 18, 2026