Identity
- Trade Name
- SmarLumi EUDAMED
- Device Name
- Antibody to Thyroglobulin (CLIA) EUDAMED
- Model / Reference
- WA48P0002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933289852333 EUDAMED
- Basic UDI-DI
- B-06933289852333 EUDAMED
- EMDN Code
- W0102100303 THYROGLOBULIN AUTOANTIBODY EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
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
SmarLumi by Guangzhou Wondfo Biotech 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-06933289852333 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000000689
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED d233bd5c-2314-47dc-8816-ea285d87e0bf 61 fields · synced Sep 17, 2026