Heelsafe
by Sumed International (UK) Ltd United Kingdom EUDAMED
Ref HSVL, HSPSS, HSPSL, HSPSMModel HEELSAFE EMDN Y090618
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506016089HSVF6 | Date13 Sep 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Heelsafe Velcro BootHeelsafe Press Stud Boot
- Model / Reference
- HEELSAFE, HSVL, HSPSS, HSPSL, HSPSM
- Primary DI / UDI-DI
- 05055826634064, 05055826634071, 05055826634095, 05055826634088
- Basic UDI-DI
- 506016089HSVF6, 506016089HSPS9B
- Direct Marketing DI
- 05055826634064050558266340710505582663409505055826634088
- EMDN Code
- Y090618 Leg and knee protections (including socks for amputated legs)
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- GB-MF-000029110
- Authorised representative
- Sumed Healthcare Ireland Ltd IE-AR-000026166
Other devices from Sumed International (UK) Ltd
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 (4)
- EUDAMED d4e64b3b-afaf-402b-87f7-5954199430ea
- EUDAMED 05055826634071|506016089HSPS9B
- EUDAMED 05055826634095|506016089HSPS9B
- EUDAMED 05055826634088|506016089HSPS9B