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Follicle Stimulating Hormone Determination Kit (Fluorescence Immunochromatograp…
EUDAMEDClass B (EU MDR)
Ref P11705Model 25 tests/box
Identity
- Trade Name
- Follicle Stimulating Hormone Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Follicle Stimulating Hormone Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP11705 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975182500126 EUDAMED
- Basic UDI-DI
- 697518250P117056P EUDAMED
- Direct Marketing DI
- 06975182500126 EUDAMED
- EMDN Code
- W0102050104 FOLLICLE STIMULATING 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
Follicle Stimulating Hormone Determination Kit (Fluorescence Immunochromatograp… 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 | 697518250P117056P | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 8d58a403-8761-4349-8de0-e7afef4628d2 61 fields · synced Oct 6, 2026