Identity
- Device Name
- WANTAI anti-TP ELISA EUDAMED
- Model / Reference
- WT-5296 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970301452515 EUDAMED
- Basic UDI-DI
- B-06970301452515 EUDAMED
- EMDN Code
- W0105010302 SYPHILIS ANTIBODY ASSAYS TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
WANTAI anti-TP ELISA by Beijing Wantai Biological Pharmacy Enterprise 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-06970301452515 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000040626
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 7011d062-3e63-442b-8e01-2dd3ede0ca0e 61 fields · synced Jul 19, 2026