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Ovulation
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 600600Ref FLH-U101H
Identity
- Trade Name
- Ovulation (LH) Enhanced Sensitivity Rapid Test Dipstick EUDAMED
- Device Name
- Ovulation EUDAMEDOvulation (LH) Enhanced Sensitivity Rapid Test Dipstick EUDAMED
- Model / Reference
- 600600 EUDAMEDFLH-U101H EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-600600N3 EUDAMED06970277513579 EUDAMED
- Basic UDI-DI
- B-600600N3 EUDAMEDB-06970277513579 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
No
EUDAMEDEUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Ovulation by Hangzhou Alltest Biotech.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-600600N3 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 169611d5-4136-4c47-af4c-dcc42b7c445b 61 fields · synced Jul 14, 2026
- EUDAMED 69d2bab3-fe27-4a4c-94e1-a031a32a0238 61 fields · synced May 18, 2026