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Tumor Necrosis Factor α Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 50tests/kitModel Reagents (Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kitRef 100tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 100tests/kitRef 50tests/kitModel Reagents (Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit
Identity
- Device Name
- Tumor Necrosis Factor α Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EUDAMED50tests/kit EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle ) 100tests/kit EUDAMED100tests/kit EUDAMEDReagents (Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719603718 EUDAMED06972719605118 EUDAMED06972719603701 EUDAMED06972719605125 EUDAMED
- Basic UDI-DI
- B-06972719603718 EUDAMEDB-06972719605118 EUDAMEDB-06972719603701 EUDAMEDB-06972719605125 EUDAMED
- EMDN Code
- W01030603 TUMOUR NECROSIS FACTORS (TNFα,TNFβ, ...) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Tumor Necrosis Factor α Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06972719603718 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000024838
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED a40c46bf-e208-421a-b50f-0087ab6004f9 61 fields · synced Oct 6, 2026
- EUDAMED 5476f5fb-b385-4a67-ad37-23f252ec96ed 61 fields · synced May 17, 2026
- EUDAMED c269ffdb-f7e7-40a9-a5a7-c662c15d45af 61 fields · synced May 17, 2026
- EUDAMED 9595e709-acb1-4ae1-952e-092b6d1981cb 61 fields · synced May 18, 2026