SSMA001E
by Sugentech, Inc. South Korea EUDAMED
Ref SSMA001EModel Surearly SMART App
EMDN W0201020292
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number88094088SSMA-001A9 | Date30 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Certificates
- CR-04-1273-919-26 Issued
Technical documentation EU IVDR
- Notified body
- Eurofins Electric & Electronics Finland Oy 0537
- Issued
- 12 Aug 2026
- Expires
- 20 Jan 2030
- V74 002704 0025 Withdrawn
Technical documentation EU IVDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 24 Jan 2025
- Expires
- 20 Jan 2030
- Reason
- Transferred to other nb
Specification
- Model / Reference
- Surearly SMART App, SSMA001E
- Primary DI / UDI-DI
- 08809408862638
- Basic UDI-DI
- 88094088SSMA-001A9
- EMDN Code
- W0201020292 Limited panel immunochemistry analysers - IVD medical device software
- Device Class
- Class B
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- KR-MF-000023952
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Sugentech, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 08809408862638|88094088SSMA-001A9