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CBZ Carbamazepine(CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref CBZ706-AE10Y, CBZ706-AE10N, CBZ706-AE20Y, CBZ706-AE20N
Identity
- Trade Name
- CBZ Carbamazepine(CLIA) EUDAMED
- Device Name
- CBZ Carbamazepine(CLIA) EUDAMED
- Model / Reference
- CBZ706-AE10Y, CBZ706-AE10N, CBZ706-AE20Y, CBZ706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-CBZ706-AEW4 EUDAMED
- Basic UDI-DI
- B-CBZ706-AEW4 EUDAMED
- EMDN Code
- W0102080201 CARBAMAZEPINE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
CBZ Carbamazepine(CLIA) by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-CBZ706-AEW4 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED c8c1b455-bb84-421c-b479-c1f82acd8404 61 fields · synced Jun 18, 2026
- EUDAMED c8c1b455-bb84-421c-b479-c1f82acd8404-1 61 fields · synced Jun 10, 2026