Qubix-Pdx
by Qubix Medicare Private Limited EUDAMED
Active
Ref QN 9221
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2025-MDR/QS-075/A | Date25 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2025-MDR/QS-075/A Amended
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 25 Sep 2026
- Expires
- 2 Dec 2030
- Reason
- Other
- 2025-MDR/TD-075/A Amended
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 25 Sep 2026
- Expires
- 2 Dec 2030
- Reason
- Other
Specification
- Device Name
- Monofilament Polydioxanone Suture
- Model / Reference
- QN 9221
- Primary DI / UDI-DI
- 08906122170794
- Basic UDI-DI
- 890612217PDW5
- EMDN Code
- H010101010101 Polydioxanone monofilament with needle for open surgery
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- IN-MF-000042759
- Authorised representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Other devices from Qubix Medicare Private Limited
Properties
Other properties (11)
- 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