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Opiate(OPI) Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VDOP-102Model VDOP
Identity
- Trade Name
- Opiate(OPI) Rapid Test EUDAMEDOpiates (OPI) Rapid Test EUDAMED
- Device Name
- Opiates (OPI) Rapid Test EUDAMED
- Model / Reference
- VDOP-102 EUDAMEDVDOP EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VDOP-102Q2 EUDAMED06937339207401 EUDAMED
- Basic UDI-DI
- B-VDOP-102Q2 EUDAMEDB-06937339207401 EUDAMED
- EMDN Code
- W0102160508 OPIATES - 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
Opiate(OPI) 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-VDOP-102Q2 | 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 47b4b188-7a02-4955-bdab-8c99418e8cd7 61 fields · synced Oct 6, 2026
- EUDAMED e8af5a3f-48e8-4862-ba6a-b08c2157a200 61 fields · synced Jul 16, 2026