← Back to catalogue
Vedolizumab CLIA Kit (Chemiluminescence Immunoassay)
EUDAMEDClass B (EU MDR)
Ref F11446Model 100 tests/box
Identity
- Trade Name
- Vedolizumab CLIA Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Vedolizumab CLIA Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100 tests/box EUDAMEDF11446 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293590742 EUDAMED
- Basic UDI-DI
- 697518250F114462L EUDAMED
- Direct Marketing DI
- 06942293590742 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
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Vedolizumab CLIA Kit (Chemiluminescence Immunoassay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class B — 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 | 697518250F114462L | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 56532d5e-45a4-42f9-8c41-f973274929ea 61 fields · synced Jul 9, 2026