Tecnodrape
by Betatex SpA Italy EUDAMED
Ref MTT04560-IModel TECNODRAPE - TELERIA STANDARD CON ANTIBATTERICO
EMDN T02010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805330078TCDGK | Date18 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- CSQ0001220523 Supplemented
Quality management system EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 2 Nov 2023
- Expires
- 23 Oct 2027
- Reason
- Add device or group
- CVD001823 Issued
Technical documentation EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 2 Nov 2023
- Expires
- 23 Oct 2027
Specification
- Device Name
- Tecnodrape - Teleria Standard Con Antibatterico
- Model / Reference
- TECNODRAPE - TELERIA STANDARD CON ANTIBATTERICO, MTT04560-I
- Primary DI / UDI-DI
- 08053807811494
- Basic UDI-DI
- 805330078TCDGK
- Direct Marketing DI
- 08053807811494
- EMDN Code
- T02010102 Incision drapes, with antibacterial agent
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000009955
Other devices from Betatex SpA
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- 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
Sources (1)
- EUDAMED e49d6971-8385-49c0-bed3-c403a48f845a