Barb-E
by TI Medical Private Limited 27 variants
Ref TI/C-BRO/01Model Monofilament Poly(p-dioxanone) Barbed Suture with needle (Violet)
Barb-E (TI/C-BRO/01) is a Class III device made by TI Medical Private Limited, registered in EUDAMED on 23 Mar 2026 (Basic UDI-DI 89042482BAR011D4), active as of 7 Nov 2026.
Active
CE MDR
Valid until
22 Mar 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number89042482BAR011D4 08909296004308 | Date23 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 89042482BAR011D4
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- Withdrawn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) Barbed Suture
- Model / reference
- Monofilament Poly(p-dioxanone) Barbed Suture with needle (Violet), TI/C-BRO/01
- Primary DI / UDI-DI
- 08909296004308
- Basic UDI-DI
- 89042482BAR011D4
- EMDN code
- H010101010104 Mounted polydioxanone monofilament with needle for tissue traction (‘barbed’)
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- IN-MF-000026561
- Authorised representative
- Obelis s.a. BE-AR-000000106