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VivaDiag N-terminal Pro-brain Natriuretic Peptide Control Solution (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VIC14-03-011Model VIC14Ref LA-137-2Model LC-101Ref LS-123-2Model LS-103Ref LA-137-1Ref LS-103-2Model LS-101
Identity
- Trade Name
- VivaDiag N-terminal Pro-brain Natriuretic Peptide Control Solution (FIA) EUDAMEDVivadiag EUDAMED
- Device Name
- VivaDiag N-terminal Pro-brain Natriuretic Peptide Control Solution (FIA) EUDAMEDLipid Testing System Control Solution EUDAMED
- Model / Reference
- VIC14 EUDAMEDVIC14-03-011 EUDAMEDLC-101 EUDAMEDLA-137-2 EUDAMEDLS-103 EUDAMEDLS-123-2 EUDAMEDLA-137-1 EUDAMEDLS-101 EUDAMEDLS-103-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VIC142M EUDAMED06975519631448 EUDAMED06975519630397 EUDAMED06975519631431 EUDAMED06975519630359 EUDAMED
- Basic UDI-DI
- B-VIC142M EUDAMEDB-06975519631448 EUDAMEDB-06975519630397 EUDAMEDB-06975519631431 EUDAMEDB-06975519630359 EUDAMED
- EMDN Code
- W0102152004 CARDIAC MARKER CONTROLS EUDAMEDW0101050202 LIPID CONTROLS EUDAMEDW0101060103 HDL TEST STRIPS EUDAMEDW0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
VivaDiag N-terminal Pro-brain Natriuretic Peptide 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-VIC142M | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED ce8b86a0-5b5b-4419-a7a9-40b10a805feb 61 fields · synced Oct 6, 2026
- EUDAMED 37c2d7fd-7519-459f-82ce-e87ecf9ed606 61 fields · synced May 17, 2026
- EUDAMED de1398b1-c68e-472e-a15b-237788b0e882 61 fields · synced May 17, 2026
- EUDAMED 58d246a4-2b4b-4c83-98e3-7310af6363ef 61 fields · synced May 18, 2026
- EUDAMED 6eb3fe9a-3c27-4c92-b8cf-3f52d1ece658 61 fields · synced May 19, 2026