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Lamotrigine CLIA Kit (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref F11417Model 100 tests/box
Identity
- Trade Name
- Lamotrigine CLIA Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Lamotrigine CLIA Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100 tests/box EUDAMEDF11417 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293590667 EUDAMED
- Basic UDI-DI
- 697518250F114172D EUDAMED
- Direct Marketing DI
- 06942293590667 EUDAMED
- EMDN Code
- W0102080212 LAMOTRIGINE 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
Lamotrigine 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 | 697518250F114172D | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 3c8b3a85-7171-40a9-b0c4-14796281797a 61 fields · synced Oct 6, 2026