← Back to catalogue
17α-Hydroxyprogesterone Control Solution (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VIC146-05-011Model VIC146
Identity
- Trade Name
- 17α-Hydroxyprogesterone Control Solution (FIA) EUDAMED
- Model / Reference
- VIC146 EUDAMEDVIC146-05-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VIC146EW EUDAMED
- Basic UDI-DI
- B-VIC146EW EUDAMED
- EMDN Code
- W0102152002 HORMONE CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
17α-Hydroxyprogesterone Control Solution (FIA) by VivaChek Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-VIC146EW | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 5eb0a3b9-9a43-4e37-aefa-683ecdd9f266 61 fields · synced Oct 7, 2026