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Treponema + VDRL ViraChip IgG Deca Kit
EUDAMEDClass C (EU MDR)
Ref V-TVCGDKModel Syphilis IgG Kit
Identity
- Trade Name
- Treponema + VDRL ViraChip IgG Deca Kit EUDAMED
- Device Name
- Treponema + VDRL ViraChip IgG Test Kit EUDAMED
- Model / Reference
- Syphilis IgG Kit EUDAMEDV-TVCGDK EUDAMED
Identifiers
- Primary DI / UDI-DI
- EVIRTVCGDK1 EUDAMED
- Basic UDI-DI
- ++EVIRSyphilisIgGKitC2 EUDAMED
- Direct Marketing DI
- EVIRTVCGDK1 EUDAMED
- EMDN Code
- W0105010303 SYPHILIS ANTIBODY IGG EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
Treponema + VDRL ViraChip IgG Deca Kit by Viramed Biotech AG — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++EVIRSyphilisIgGKitC2 | Class C | Active |
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Manufacturer
- Manufacturer
- Viramed Biotech AG
- EUDAMED SRN
- DE-MF-000020368
Sources (1)
- EUDAMED 1425dbc2-b390-45ca-86e2-2b5fd58bd92d 61 fields · synced Jun 19, 2026