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Benzodiazepine(BZO) Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VDBZ-101Ref VDBZ-102Model VDBZ
Identity
- Trade Name
- Benzodiazepine(BZO) Rapid Test EUDAMEDBenzodiazepines (BZO) Rapid Test EUDAMED
- Device Name
- Benzodiazepines (BZO) Rapid Test EUDAMED
- Model / Reference
- VDBZ-101 EUDAMEDVDBZ EUDAMEDVDBZ-102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VDBZ-101N5 EUDAMED06937339207319 EUDAMED
- Basic UDI-DI
- B-VDBZ-101N5 EUDAMEDB-06937339207319 EUDAMED
- EMDN Code
- W0102160504 BENZODIAZEPINES - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
Benzodiazepine(BZO) Rapid Test by VivaChek Biotech (Hangzhou) 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-VDBZ-101N5 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED bfe908e9-359c-4792-ab7e-49067c5e16c1 61 fields · synced Oct 6, 2026
- EUDAMED 17349f09-8434-4827-adf9-ae04f6876178 61 fields · synced Jul 17, 2026