SafeSheath II
Ref SS5
SafeSheath II (SS5) is a Class III device made by Oscor Inc., registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI B-00891492002203), active as of 25 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-00891492002203 00891492002203 | Date14 Oct 2026 | StatusActive |
Official records
- EUDAMED public site B-00891492002203
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / reference
- SS5
- Primary DI / UDI-DI
- 00891492002203
- Basic UDI-DI
- B-00891492002203
- EMDN code
- C0503 Cardiovascular introducer sheaths, peel-away
- Device class
- Class III
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000005944
- Authorised representative
- MDSS GmbH DE-AR-000005430
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