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- Withdrawn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
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) 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
- 08909296012945, 08904248279667, 08904248208469, 08904248208353, 08904248257603, 08904248208315, 08904248208551, 08904248297340, 08904248284746, 08909296024412, 08904248273405, 08904248244184, 08904248207943, 08904248273412, 08904248257627, 08904248279780, 08904248278196, 08904248275201, 08904248276048, 08904248276604, 08904248274921, 08909296020346, 08904248208162, 08904248292598, 08904248277199, 08904248208391, 08904248207059, 08909296024436, 08904248288935, 08904248279674, 08904248279452, 08904248277182, 08904248290242, 08904248274938, 08904248285514, 08909296021619, 08904248287815, 08904248292604, 08904248257177, 08904248208001, 08909296001215, 08904248277205, 08909296012969, 08909296020339, 08904248257610, 08904248284142, 08904248208155, 08904248273740, 08904248208278, 08909296021602
- 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