Thermoskin EXO Adjustable Back Stabilising Support
by United Pacific Industries Pty Ltd EUDAMED
Active
Ref 80113
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number609580TSKN82671ML | Date9 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Thermoskin
- Model / Reference
- 80113
- Primary DI / UDI-DI
- 00609580801139
- Basic UDI-DI
- 609580TSKN82671ML
- EMDN Code
- Y060308 Lumbosacral spine orthoses
- Device Class
- Class I
- Market of Registration
- Finland
Manufacturer details
- EUDAMED SRN
- AU-MF-000002766
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from United Pacific Industries Pty. Ltd.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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