← Back to catalogue
Luteinizing Hormone Determination Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass B (EU MDR)
Ref P11706Model 25 tests/box
Identity
- Trade Name
- Luteinizing Hormone Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Luteinizing Hormone Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP11706 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975182500102 EUDAMED
- Basic UDI-DI
- 697518250P117066R EUDAMED
- Direct Marketing DI
- 06975182500102 EUDAMED
- EMDN Code
- W0102050105 LUTEINISING HORMONE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Luteinizing Hormone Determination Kit (Fluorescence Immunochromatographic Assay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in…
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 | 697518250P117066R | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 11fca73b-2cc2-4ff8-b28c-b78809c82ff3 61 fields · synced Oct 6, 2026