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Human Tumor Specific Protein 70 ELISA Kit
EUDAMEDClass IVD General (EU MDR)
Ref KD7001-96Model 96 tests/kit
Identity
- Device Name
- Human Tumor Specific Protein 70 ELISA Kit EUDAMED
- Model / Reference
- 96 tests/kit EUDAMEDKD7001-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974873630098 EUDAMED
- Basic UDI-DI
- B-06974873630098 EUDAMED
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
Human Tumor Specific Protein 70 ELISA Kit by Jiangsu Code Biomedical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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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-06974873630098 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Code Biomedical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000048158
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 506672de-0b5c-4365-bcb8-4f77ed3ba02c 61 fields · synced Jul 11, 2026