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Drugs of Abuse Rapid Test Device
EUDAMEDClass IVD General (EU MDR)
Ref VDABP-102Ref VDCOModel VD
Identity
- Trade Name
- Drugs of Abuse Rapid Test Device EUDAMED
- Device Name
- Drugs of Abuse Rapid Test Device EUDAMED
- Model / Reference
- VDABP-102 EUDAMEDVD EUDAMEDVDCO EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VDABP-102AH EUDAMED06937339210319 EUDAMED
- Basic UDI-DI
- B-VDABP-102AH EUDAMEDB-06937339210319 EUDAMED
- EMDN Code
- W0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER 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
Drugs of Abuse Rapid Test Device 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-VDABP-102AH | 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 5127024e-1b06-4399-bc83-41ccb453871a 61 fields · synced Oct 7, 2026
- EUDAMED f5bc5a16-064f-4277-9f36-50fa2fd01677 61 fields · synced Jul 21, 2026