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TNF-alpha (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320513502Model 2×50TRef 0320513503Model 100T
Identity
- Trade Name
- TNF-alpha (eCLIA) EUDAMED
- Device Name
- TNF-alpha (eCLIA) EUDAMED
- Model / Reference
- 2×50T EUDAMED0320513502 EUDAMED100T EUDAMED0320513503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978139072080 EUDAMED06978139072059 EUDAMED
- Basic UDI-DI
- B-06978139072080 EUDAMEDB-06978139072059 EUDAMED
- EMDN Code
- W01030603 TUMOUR NECROSIS FACTORS (TNFα,TNFβ, ...) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
TNF-alpha (eCLIA) by Shenzhen Lifotronic Technology 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-06978139072080 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED ca176532-2e1a-458d-9dab-57c00e049b55 61 fields · synced Jul 16, 2026
- EUDAMED 147f765d-ad44-4225-a022-c5f1f601335a 61 fields · synced May 18, 2026