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Valproic Acid and Carbamazepine Control
EUDAMEDClass IVD General (EU MDR)
Ref LBZK905AModel 2Levels×1×1mL
Identity
- Trade Name
- Valproic Acid and Carbamazepine Control EUDAMED
- Device Name
- Valproic Acid and Carbamazepine Control EUDAMED
- Model / Reference
- 2Levels×1×1mL EUDAMEDLBZK905A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978945081207 EUDAMED
- Basic UDI-DI
- B-06978945081207 EUDAMED
- EMDN Code
- W0102080299 CENTRAL NERVOUS SYSTEM TDM - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Valproic Acid and Carbamazepine Control by Jiangxi Medicalsystem Biological Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06978945081207 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000050651
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 27ad7604-6518-450a-bab1-68efd1057fc9 61 fields · synced Jun 18, 2026