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Trastuzumab CLIA kit (Chemiluminescence Immunoassay)W01020899
EUDAMEDClass C (EU MDR)
Ref F11439Model 100 tests/box
Identity
- Trade Name
- Trastuzumab CLIA kit (Chemiluminescence Immunoassay)W01020899 EUDAMED
- Device Name
- Trastuzumab CLIA kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100 tests/box EUDAMEDF11439 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293590360 EUDAMED
- Basic UDI-DI
- 697518250F114392P EUDAMED
- Direct Marketing DI
- 06942293590360 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
Trastuzumab CLIA kit (Chemiluminescence Immunoassay)W01020899 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 | 697518250F114392P | 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 3d6dfb95-820a-4f88-a153-d88fee325d8b 61 fields · synced Oct 6, 2026