TraxGuard Tracheostomy and Laryngectomy Protector. Small Black
by Insight Medical Products Ltd EUDAMED
Active
Ref TB/353
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506041364TF014W5 | Date19 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- Withdrawn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
- TraxGuard Tracheostomy and Laryngectomy Protector
- Model / Reference
- TB/353
- Primary DI / UDI-DI
- 05060413640755
- Basic UDI-DI
- 506041364TF014W5
- Unit of Use DI
- 25060413640759
- EMDN Code
- R01058002 Tracheostomy filters
- Device Class
- Class I
- Market of Registration
- Malta
Manufacturer details
- EUDAMED SRN
- GB-MF-000004395
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Insight Medical Products 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