Identity
- Device Name
- NovaLisa® TBE/FSME IgG EUDAMED
- Model / Reference
- TICG0440 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +ENTITICG04400- EUDAMED
- Basic UDI-DI
- B-+ENTITICG04400- EUDAMED
- EMDN Code
- W0105040612 FSME VIRUS EUDAMED
Classification
- Device Class
- Class IVD General 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
NovaLisa® TBE/FSME IgG by Gold Standard Diagnostics Frankfurt GmbH — 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-+ENTITICG04400- | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics Frankfurt GmbH
- EUDAMED SRN
- DE-MF-000025020
Sources (1)
- EUDAMED f253bca2-f07e-44ed-ad5e-192ca60dea17 61 fields · synced Jul 8, 2026