Isol/8
by Isol8 Healthcare Ltd EUDAMED
Active
Ref IS8RM04PModel FLUIDSAFE Surgical Mask
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0539154127IS8SMXG | Date30 Apr 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Surgical Face Mask
- Model / Reference
- FLUIDSAFE Surgical Mask, IS8RM04P
- Primary DI / UDI-DI
- 05391541270348
- Basic UDI-DI
- 0539154127IS8SMXG
- EMDN Code
- T020604 Medical use face masks, type ii and iir
- 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