One-Step Drug of Abuse Test Oxycodone (OXY)
by W.H.P.M. Bioresearch & Technology Co., Ltd.
Ref WH-DU-S0x1501; WH-DU-S0x1502; WH-DU-S0x1503; WH-DU-S0x1504Model Strip; Cassette; Dipcard; Cup.
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-6909620WHDUSOXYQ2Z7 D-6909620WHDUSOXYQ2Z7 | Date10 Mar 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Drugs of Abuse Tests (Oxycodone)
- Model / Reference
- Strip, Cassette, Dipcard, Cup., WH-DU-S0x1501, WH-DU-S0x1502, WH-DU-S0x1503, WH-DU-S0x1504
- Primary DI / UDI-DI
- D-6909620WHDUSOXYQ2Z7
- Basic UDI-DI
- B-6909620WHDUSOXYQ2Z7
- EMDN Code
- W0102160599 Drugs of abuse/toxicology rt & poc - other
- Device Class
- Class IVD devices for self-testing
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000003007
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from W.H.P.M. Bioresearch & Technology Co., Ltd.
See all devices from W.H.P.M. Bioresearch & Technology Co., Ltd. →
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No