ResistancePlus MG S2A Positive Control
by SpeeDx Pty. Ltd. Australia EUDAMED
Ref S2A-95004Model 1.0 EMDN W0105080808
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number9352224020001W6 | Date25 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- ResistancePlus MG
- Model / Reference
- 1.0, S2A-95004
- Primary DI / UDI-DI
- 09352224000399
- Basic UDI-DI
- 9352224020001W6
- Direct Marketing DI
- 09352224000399
- EMDN Code
- W0105080808 All infectious diseases controls - nat
- Device Class
- Class C
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- AU-MF-000016649
- Authorised representative
- MedEnvoy Global BV NL-AR-000024028
Other devices from SpeeDx Pty. Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 358a42a7-dbbd-44ca-b420-204724bf738b