Barb-E
by TI Medical Private Limited 11 variants
Ref TI/C-BRO/01Model Monofilament Poly(p-dioxanone) Barbed Suture with 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- Withdrawn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
EU market availability
Made available in 32 countries, as listed in EUDAMED:
- Austria since 9 Jun 2016
- Belgium since 9 Jun 2016
- Bulgaria since 9 Jun 2016
- Croatia since 9 Jun 2016
- Cyprus since 9 Jun 2016
- Czechia since 9 Jun 2016
- Denmark since 9 Jun 2016
- Estonia since 9 Jun 2016
- Finland since 9 Jun 2016
- France since 9 Jun 2016
- Germany since 9 Jun 2016
- Greece since 9 Jun 2016
- Hungary since 9 Jun 2016
- Iceland since 9 Jun 2016
- Ireland since 9 Jun 2016
- Italy since 9 Jun 2016
- Latvia since 9 Jun 2016
- Liechtenstein since 9 Jun 2016
- Lithuania since 9 Jun 2016
- Luxembourg since 9 Jun 2016
- Malta since 9 Jun 2016
- Netherlands since 9 Jun 2016
- Northern Ireland since 9 Jun 2016
- Norway since 9 Jun 2016
- Poland since 9 Jun 2016
- Portugal since 9 Jun 2016
- Romania since 9 Jun 2016
- Slovakia since 9 Jun 2016
- Slovenia since 9 Jun 2016
- Spain since 9 Jun 2016
- Sweden since 9 Jun 2016
- Türkiye since 9 Jun 2016
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
- 08904248281622, 08904248274631, 08904248274662, 08904248245273, 08904248274570, 08909296008535, 08904248274600, 08909296019319, 08904248281530, 08909296005299, 08904248264380, 08904248274655, 08904248290037, 08904248281677, 08904248281516, 08904248246300, 08904248246294, 08904248281554, 08904248274549, 08909296008368, 08904248274211, 08909296019340, 08904248296046, 08904248254930, 08904248255098, 08904248274587, 08904248242364, 08909296005275, 08904248274617, 08904248292109, 08904248250116, 08904248281561, 08904248274693, 08904248296015, 08904248274648, 08904248281660, 08904248252240, 08904248296008, 08904248292123, 08904248274556, 08904248246317, 08904248243552, 08904248292741, 08904248297197, 08904248244337, 08909296008351, 08904248274709, 08904248292703, 08909296008511, 08904248288591
- Basic UDI-DI
- 89042482BAR011D4
- EMDN Code
- H010101010104 Mounted polydioxanone monofilament with needle for tissue traction (‘barbed’)
- 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