← Back to catalogue
Ketamine(KET) Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VDKET-A101Ref VDKET-A102
Identity
- Trade Name
- Ketamine(KET) Rapid Test EUDAMED
- Model / Reference
- VDKET-A101 EUDAMEDVDKET-A102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VDKET-A101GY EUDAMEDD-VDKET-A102H2 EUDAMED
- Basic UDI-DI
- B-VDKET-A101GY EUDAMEDB-VDKET-A102H2 EUDAMED
- EMDN Code
- W0102160599 DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
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
Ketamine(KET) 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-VDKET-A101GY | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 34a3d4bd-f24e-4cf2-b2df-f8fa13e59e0d 61 fields · synced Oct 6, 2026
- EUDAMED 95b63570-0f2c-4be6-a875-d6efdb798312 61 fields · synced May 18, 2026