One-Step FSH Test
by W.H.P.M. Bioresearch & Technology Co., Ltd.
Ref WH-FT-S0x0301; WH-FT-S0x0302; WH-FT-S0x0303; WH-FT-S0x0307Model Strip; Cassette; Dipcard; Midstream
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-6909620WHSFSH9MLB D-6909620WHSFSH9MLB | 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- Withdrawn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
- Folliclc Stimulating Hormone Tests
- Model / Reference
- Strip, Cassette, Dipcard, Midstream, WH-FT-S0x0301, WH-FT-S0x0302, WH-FT-S0x0303, WH-FT-S0x0307
- Primary DI / UDI-DI
- D-6909620WHSFSH9MLB
- Basic UDI-DI
- B-6909620WHSFSH9MLB
- EMDN Code
- W0102160301 Fsh - 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