One-Step Drug of Abuse Test -Amphetamine(AMP)
by W.H.P.M. Bioresearch & Technology Co., Ltd.
Ref WH-DU-S0x0101; WH-DU-S0x0102; WH-DU-S0x0103; WH-DU-S0x0104Model 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-6909620WHDUSAMPL9QJ D-6909620WHDUSAMPL9QJ | 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- Withdrawn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 (Amphetamine)
- Model / Reference
- Strip, Cassette, Dipcard, Cup, WH-DU-S0x0101, WH-DU-S0x0102, WH-DU-S0x0103, WH-DU-S0x0104
- Primary DI / UDI-DI
- D-6909620WHDUSAMPL9QJ
- Basic UDI-DI
- B-6909620WHDUSAMPL9QJ
- EMDN Code
- W0102160501 Amphetamines - rt & poc
- 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.
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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