Isol/8
by Isol8 Healthcare Ltd EUDAMED
Active
Ref IS8SG01Model ISOL/8 SMS Medical Gown
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number539154127IS8MGBF | Date25 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- SMS Medical Gown
- Model / Reference
- ISOL/8 SMS Medical Gown, IS8SG01
- Primary DI / UDI-DI
- 05391541270492
- Basic UDI-DI
- 539154127IS8MGBF
- EMDN Code
- T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- IE-MF-000012420
From the manufacturer
Manufacturer's product page: ISOL8 Healthcare Awarded onto NHS Supply Chain Framework for Blood Collection Devices
Other devices from Isol8 Healthcare Ltd
Properties
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