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LH Ovulation Test (Colloidal Gold)
EUDAMEDClass IVD General (EU MDR)
Ref LH3UST- 40Model 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 EUDAMEDLH3UST- 40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952062711490 EUDAMED
- Basic UDI-DI
- B-06952062711490 EUDAMED69520627J002KY EUDAMED
- Unit of Use DI
- 06952062712701 EUDAMED
- EMDN Code
- W0102050105 LUTEINISING HORMONE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass 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 IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06952062711490 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06952062711490 | Class IVD General | 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 (2)
- EUDAMED 58b9696b-5a22-476c-97db-4d337c9fb435 61 fields · synced Oct 10, 2026
- EUDAMED c9e0f45d-e4f8-40a8-8491-b372d17e3671 61 fields · synced Oct 10, 2026