SilkyBarrier®
by Synkotech Biocompatible Materials S.L Spain EUDAMED
Ref SB_SPONGE1Model SB
EMDN M9002
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8437025406SBGV | Date25 May 2026 | StatusWithdrawn |
Coverage
- Withdrawn
- Not covered
European Union — CE/MDR Withdrawn
Specification
- Model / Reference
- SB, SB_SPONGE1
- Primary DI / UDI-DI
- 08437025406715
- Basic UDI-DI
- 8437025406SBGV
- EMDN Code
- M9002 Protective devices, lubricants and soothing devices (sprays, gels, fluids and creams)
- Device Class
- Class I
Manufacturer details
- EUDAMED SRN
- ES-MF-000031010
Other devices from Synkotech Biocompatible Materials S.L
See all devices from Synkotech Biocompatible Materials S.L →
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED a4bb1720-e205-41ab-8b80-cece575d7c9a