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Prolactin Determination Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass B (EU MDR)
Ref P11704Model 25 tests/box
Identity
- Trade Name
- Prolactin Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Prolactin Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP11704 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975182500119 EUDAMED
- Basic UDI-DI
- 697518250P117046M EUDAMED
- Direct Marketing DI
- 06975182500119 EUDAMED
- EMDN Code
- W0102050108 PROLACTIN 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
Prolactin Determination Kit (Fluorescence Immunochromatographic Assay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — IVDR — listed in EUDAMED
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 | 697518250P117046M | 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 1cc800d5-0c9c-4fd7-bdeb-10a05afc1e45 61 fields · synced Oct 6, 2026