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LH Ovulation Test (Colloidal Gold)
EUDAMEDClass B (EU MDR)
Ref LH1UST- 25Model Cassette Strip Midstream
Identity
- Trade Name
- LH Ovulation Test (Colloidal Gold) EUDAMED
- Device Name
- LH Ovulation Test (Colloidal Gold) EUDAMED
- Model / Reference
- Cassette Strip Midstream EUDAMEDLH1UST- 25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062770602 EUDAMED
- Basic UDI-DI
- 69520627J002KY EUDAMED
- Unit of Use DI
- 06952062712701 EUDAMED
- EMDN Code
- W0102050105 LUTEINISING HORMONE EUDAMED
Classification
- Device Class
- Class B 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
LH Ovulation Test (Colloidal Gold) by Anhui Deepblue Medical Technology Co., 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 | 69520627J002KY | Class B | Active |
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Manufacturer
- Manufacturer
- Anhui Deepblue Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018785
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED f831852f-c595-4d27-97a9-6bbf4f3298bc 61 fields · synced Oct 7, 2026