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Tuberculosis IgG/IgM Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VITB-402Model VITB
Identity
- Trade Name
- Tuberculosis IgG/IgM Rapid Test EUDAMED
- Device Name
- Tuberculosis IgG/IgM Rapid Test EUDAMED
- Model / Reference
- VITB-402 EUDAMEDVITB EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VITB-402QD EUDAMED06937339209573 EUDAMED
- Basic UDI-DI
- B-VITB-402QD EUDAMEDB-06937339209573 EUDAMED
- EMDN Code
- W0105090199 BACTERIOLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Tuberculosis IgG/IgM Rapid Test 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-VITB-402QD | 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 4ed608de-3355-4243-865a-0f3822ca5e64 61 fields · synced Oct 6, 2026
- EUDAMED 2f65aae9-0704-4f16-ad63-057e23d2d90e 61 fields · synced Jul 9, 2026