Isol/8
by Isol8 Healthcare Ltd EUDAMED
Active
Ref IS8P02Model ISOL/8 Plush Standard Surgical Gown L
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-05391541270164 | Date25 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- Surgical Gown
- Model / Reference
- ISOL/8 Plush Standard Surgical Gown L, IS8P02
- Primary DI / UDI-DI
- 05391541270164
- Basic UDI-DI
- B-05391541270164
- EMDN Code
- T020401 Standard surgical gowns
- 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 (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No