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Multi-Drugs Rapid Test Key Cup
EUDAMEDClass IVD General (EU MDR)
Ref VDKC-1108-001Ref VDSAKC-158Model VDSAKC
Identity
- Trade Name
- Multi-Drugs Rapid Test Key Cup EUDAMED
- Device Name
- Multi-Drugs Rapid Test Key Cup EUDAMED
- Model / Reference
- VDKC-1108-001 EUDAMEDVDSAKC EUDAMEDVDSAKC-158 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VDKC-1108-001KA EUDAMED06937339210043 EUDAMED
- Basic UDI-DI
- B-VDKC-1108-001KA EUDAMEDB-06937339210043 EUDAMED
- EMDN Code
- W0102160511 MULTIPLE DRUGS OF ABUSE/TOXICOLOGY 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
Multi-Drugs Rapid Test Key Cup 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-VDKC-1108-001KA | 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 1f0cf356-8569-4acd-9cb3-caa89d272054 61 fields · synced Oct 5, 2026
- EUDAMED c14623d4-8c2a-4262-a05c-2991cfdc1630 61 fields · synced Aug 4, 2026