Monolus
by TI Medical Private Limited 14 variants
Ref TI/C-BRO/01Model Monofilament Poly (Glycolide Co-Caprolactone) 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- Withdrawn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 (Glycolide Co-Caprolactone) Suture
- Model / Reference
- Monofilament Poly (Glycolide Co-Caprolactone) Suture with needle (Violet), TI/C-BRO/01
- Primary DI / UDI-DI
- 08904248207608, 08909296025303, 08909296021916, 08904248207493, 08904248277335, 08904248268159, 08904248273733, 08904248268180, 08909296021589, 08904248207028, 08904248207646, 08904248207264, 08904248207233, 08904248207202, 08904248207509, 08904248262218, 08904248262133, 08904248273726, 08904248276147, 08904248278394, 08904248266445, 08904248262225, 08904248297319, 08904248207219, 08904248207103, 08904248207387, 08904248262249, 08904248207530, 08904248207523, 08904248206984, 08904248207677, 08904248207639, 08904248253162, 08904248207547, 08904248207226, 08904248262195, 08904248293564, 08904248262188, 08904248207561, 08904248207363, 08909296020414, 08904248295636, 08904248207141, 08904248207066, 08909296024399, 08904248278189, 08909296020407, 08909296013034, 08909296020728, 08904248262140
- Basic UDI-DI
- 89042482MON006MQ
- EMDN Code
- H010101010301 Poliglecaprone and derivatives monofilament with needle
- 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