Sst-4100
Sst-4100 is a medical device (EU MDD Class I) made by Shinyoung for M Co., Ltd., registered in EUDAMED on 10 Sep 2024 (Basic UDI-DI B-08809832900210), active as of 22 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08809832900210 08809832900210 | Date10 Sep 2024 | StatusActive |
Official records
- EUDAMED public site B-08809832900210
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device name
- Sst-4100
- Primary DI / UDI-DI
- 08809832900210
- Basic UDI-DI
- B-08809832900210
- EMDN code
- Z11039080 Various radiodiagnostic and interventional instruments - hardware accessories
- Device class
- Class I
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000043632
- Authorised representative
- Obelis s.a. BE-AR-000000106
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