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Alpha Tumor Necrosis Factor (TNFα) Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref DC0601Model 2×50 test/box Calibrator:0.5mL×2
Identity
- Trade Name
- Alpha Tumor Necrosis Factor (TNFα) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- Alpha Tumor Necrosis Factor (TNFα) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 2×50 test/box Calibrator:0.5mL×2 EUDAMEDDC0601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970522642290 EUDAMED
- Basic UDI-DI
- B-06970522642290 EUDAMED
- EMDN Code
- W01030603 TUMOUR NECROSIS FACTORS (TNFα,TNFβ, ...) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Alpha Tumor Necrosis Factor (TNFα) Assay Kit (Chemiluminescent Immunoassay) by Sichuan Orienter Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in…
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-06970522642290 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 27c1fdec-06ab-44a0-97a8-21169e646326 61 fields · synced Jul 22, 2026