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Certolizumab CLIA kit (Chemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref F11471Model 100 tests/box
Identity
- Trade Name
- Certolizumab CLIA kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Certolizumab CLIA kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100 tests/box EUDAMEDF11471 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293552337 EUDAMED
- Basic UDI-DI
- 697518250F114712K EUDAMED
- Direct Marketing DI
- 06942293552337 EUDAMED
- EMDN Code
- W0102080799 AUTOIMMUNE DISEASE TDM - OTHER EUDAMED
Classification
- Device Class
- Class B 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
The Certolizumab CLIA kit (Chemiluminescence Immunoassay) is a highly accurate and reliable diagnostic tool used in medical settings to monitor patients' responses to treatment for certain autoimmune diseases. This device has undergone rigorous testing and has been certified by regulatory bodies, ensuring its safety and efficacy.
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 | 697518250F114712K | Class B | 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 20e3d170-87b0-4ade-9cf5-760849307f57 61 fields · synced Jun 25, 2026