BIOSYNEX AMPLIQUICK STI Panel I
by Biosynex France EUDAMED
Ref 3150070_SEC02, 3150070_SEC01Model BIOSYNEX AMPLIQUICK STI Panel I EMDN W0105070501
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number353267F00204P7T | Date5 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- BIOSYNEX AMPLIQUICK STI Panel I, 3150070_SEC02, 3150070_SEC01
- Primary DI / UDI-DI
- 03532670103585, 03532670103578
- Basic UDI-DI
- 353267F00204P7T
- EMDN Code
- W0105070501 Stis / stds (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex na reagents
- Device Class
- Class C
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000014073
Other devices from Biosynex
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED b67855da-3af6-458f-9712-c9fa14087c4f
- EUDAMED 03532670103578|353267F00204P7T