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H.Pylori Antibody Control Solution (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VIC82-01-011Model VIC82
Identity
- Trade Name
- H.Pylori Antibody Control Solution (FIA) EUDAMEDH. pylori Antibody Control Solution (FIA) EUDAMED
- Device Name
- H. pylori Antibody Control Solution (FIA) EUDAMED
- Model / Reference
- VIC82 EUDAMEDVIC82-01-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VIC8236 EUDAMED06937339209214 EUDAMED
- Basic UDI-DI
- B-VIC8236 EUDAMEDB-06937339209214 EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER 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
EUDAMEDEUDAMED
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
H.Pylori Antibody Control Solution (FIA) by VivaChek Biotech (Hangzhou) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-VIC8236 | 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 (2)
- EUDAMED a6b81e8b-6a55-48e5-8d32-bdeac4d3ff8e 61 fields · synced Oct 6, 2026
- EUDAMED 2ae1ff99-cd7b-4490-ada8-ef52c9b41a5b 61 fields · synced Jul 11, 2026