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Free Anti Pembrolizumab CLIA kit (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref F11470Model 100 tests/box
Identity
- Trade Name
- Free Anti Pembrolizumab CLIA kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Free Anti Pembrolizumab CLIA kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100 tests/box EUDAMEDF11470 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293591800 EUDAMED
- Basic UDI-DI
- 697518250F114702H EUDAMED
- Direct Marketing DI
- 06942293591800 EUDAMED
- EMDN Code
- W01020899 THERAPEUTIC DRUG MONITORING - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy 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
New Device
Yes
EUDAMED
Free Anti Pembrolizumab CLIA kit (Chemiluminescence Immunoassay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697518250F114702H | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 5ccb8cea-8338-4080-9484-a2285a5d9d4f 61 fields · synced Oct 8, 2026