Welknit-3D Anatomical Mesh
by Qubix Medicare Private Limited 4 variants
Ref QTM 3DXLR
Active
CE MDR
Valid until
2 Dec 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2025-MDR/QS-079/A | Date8 Jun 2026 | StatusActive |
Certificates
- 2025-MDR/QS-079/A Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 8 Jun 2026
- Expires
- 2 Dec 2030
- Reason
- Other
- 2025-MDR/TD-079/A Active
Technical documentation EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 8 Jun 2026
- Expires
- 2 Dec 2030
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Monofilament Polypropylene Mesh
- Model / Reference
- QTM 3DXLR
- Primary DI / UDI-DI
- 08906122173153
- Basic UDI-DI
- 890612217PMWP
- EMDN Code
- P900202 Polypropylene surgical meshes
- Device Class
- Class III
- EU 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