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Valproic Acid Determination Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass C (EU MDR)
Ref P11407Model 25 tests
Identity
- Trade Name
- Valproic Acid Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Valproic Acid Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests EUDAMEDP11407 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975182500249 EUDAMED
- Basic UDI-DI
- 697518250P114076C EUDAMED
- Direct Marketing DI
- 06975182500249 EUDAMED
- EMDN Code
- W0102080210 VALPROIC ACID EUDAMED
Classification
- Device Class
- Class C 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
Valproic Acid Determination Kit (Fluorescence Immunochromatographic Assay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — 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 | 697518250P114076C | Class C | 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 7d0f20df-9374-4084-a947-23e0e5be6d99 61 fields · synced Oct 6, 2026