Isolation gown SMIG2
by Suirsafe Technologies Ltd. EUDAMED
Active
Ref SMIG2
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberPP12054SMIG35492.71 | Date8 Nov 2021 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Isolation gown SMIG1
- Model / Reference
- SMIG2
- Primary DI / UDI-DI
- 111785883351
- Basic UDI-DI
- PP12054SMIG35492.71
- Unit of Use DI
- 111788947273
- 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-000004594
Other devices from Suirsafe Technologies 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