STANDARD™ M10 STI Panel
by SD Biosensor Inc. South Korea EUDAMED
Ref 11STI10AModel M10-STI-01 EMDN W0105070501
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number88001117IPCA01MA10X9 | Date19 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- M10-STI-01, 11STI10A
- Primary DI / UDI-DI
- 08800111719004
- Basic UDI-DI
- 88001117IPCA01MA10X9
- 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
- Italy
Manufacturer details
- EUDAMED SRN
- KR-MF-000009168
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Sd Biosensor
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 (1)
- EUDAMED 08800111719004|88001117IPCA01MA10X9