Prolus
by TI Medical Private Limited EUDAMED
Active
Ref TI/C-BRO/01Model Monofilament Polypropylene suture with needle,Monofilament Polypropylene suture without needle
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number89042482PRO007Q9 | Date18 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2975-MED-2608201 Issued
Quality management system EU MDR
- Notified body
- Notified body 2975
- Issued
- 23 Mar 2026
- Expires
- 22 Mar 2031
Specification
- Device Name
- Monofilament Polypropylene suture
- Model / Reference
- Monofilament Polypropylene suture with needle, Monofilament Polypropylene suture without needle, TI/C-BRO/01
- Primary DI / UDI-DI
- 08904248211773
- Basic UDI-DI
- 89042482PRO007Q9
- EMDN Code
- H010201010401 Polypropylene monofilament with needle for open surgery
- Device Class
- Class IIb
- 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
Show 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