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Human Tumor Specific Protein 70 ELISA Control Kit
EUDAMEDClass IVD General (EU MDR)
Ref KD7001-CModel L1:Level 1(lyophilized powder x1 bottle, redissolved volume 1.2 mL);L2: Level 2(lyophilized powder x1 bottle, redissolved volume 1.2 mL)
Identity
- Device Name
- Human Tumor Specific Protein 70 ELISA Control Kit EUDAMED
- Model / Reference
- L1:Level 1(lyophilized powder x1 bottle, redissolved volume 1.2 mL);L2: Level 2(lyophilized powder x1 bottle, redissolved volume 1.2 mL) EUDAMEDKD7001-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974873630104 EUDAMED
- Basic UDI-DI
- B-06974873630104 EUDAMED
- EMDN Code
- W0102152005 TUMOUR MARKER CONTROLS 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
Human Tumor Specific Protein 70 ELISA Control Kit by Jiangsu Code Biomedical Technology 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-06974873630104 | 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 40352dd0-1221-4c14-a51f-7f9abd08bdd1 61 fields · synced Oct 6, 2026