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Treponema + VDRL ViraChip IgM Test Kit
EUDAMEDClass C (EU MDR)
Ref V-TVCMOKModel Syphilis IgM Kit
Identity
- Trade Name
- Treponema + VDRL ViraChip IgM Test Kit EUDAMED
- Device Name
- Treponema + VDRL ViraChip IgM Test Kit EUDAMED
- Model / Reference
- Syphilis IgM Kit EUDAMEDV-TVCMOK EUDAMED
Identifiers
- Primary DI / UDI-DI
- EVIRTVCMOK1 EUDAMED
- Basic UDI-DI
- ++EVIRSyphilisIgMKitDC EUDAMED
- Direct Marketing DI
- EVIRTVCMOK1 EUDAMED
- EMDN Code
- W0105010304 SYPHILIS ANTIBODY IGM 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 IgM Test 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 | ++EVIRSyphilisIgMKitDC | Class C | Active |
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Manufacturer
- Manufacturer
- Viramed Biotech AG
- EUDAMED SRN
- DE-MF-000020368
Sources (1)
- EUDAMED dba448f5-83ee-4418-afcd-aaee239d9639 61 fields · synced Jul 9, 2026