Filaxyn™ Polydioxanone Suture
by Meril Endo Surgery Pvt. Ltd. 149 variants
Ref ME/BRC/007
Active
CE MDR
Valid until
15 Jan 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberG70 105557 0010 | Date30 Jun 2026 | StatusActive |
Certificates
- G70 105557 0010 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 30 Jun 2026
- Expires
- 15 Jan 2030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Filaxyn™/Aspiron™ Absorbable Poly (P-Dioxanone) Surgical Suture
- Model / Reference
- ME/BRC/007
- Primary DI / UDI-DI
- 18904255216102
- Basic UDI-DI
- 89042552MES_PDX04XX
- EMDN Code
- H010101010101, H010101010103
- Device Class
- Class III
- EU market of registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- IN-MF-000010999
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Meril Endo Surgery Pvt. Ltd.
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