Mass
by TI Medical Private Limited 42 variants
Ref TI/C-BRO/01Model Monofilament Poly(p-dioxanone) Suture with needle (Violet), Monofilament Poly(p-dioxanone) Suture without needle (Violet)
Active
CE MDR
Valid until
22 Mar 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2975-MED-2608201 | Date23 Mar 2026 | StatusActive |
Certificates
- 2975-MED-2608201 Active
Quality management system EU MDR
- Certifier
- SZUTEST Konformitätsbewertungsstelle GmbH 2975
- Issued
- 23 Mar 2026
- Expires
- 22 Mar 2031
- 2975-MED-2608201-D01 Active
Technical documentation EU MDR
- Certifier
- SZUTEST Konformitätsbewertungsstelle GmbH 2975
- Issued
- 23 Mar 2026
- Expires
- 22 Mar 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Monofilament Poly(p-dioxanone) Suture
- Model / Reference
- Monofilament Poly(p-dioxanone) Suture with needle (Violet), Monofilament Poly(p-dioxanone) Suture without needle (Violet), TI/C-BRO/01
- Primary DI / UDI-DI
- 08904248208476
- Basic UDI-DI
- 89042482MAS005HX
- EMDN Code
- H010101010101 Polydioxanone monofilament with needle for open surgery
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- IN-MF-000026561
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from TI Medical 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