Sorath, Sorath Ortho
by Sigma Surgical Private Limited EUDAMED
Active
Ref G04104300Model Elizaro Wire, Dia. 1.5 mm
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-G500G041043000 | Date27 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Wires and Pins
- Model / Reference
- Elizaro Wire, Dia. 1.5 mm, G04104300
- Primary DI / UDI-DI
- G500G041043000
- Basic UDI-DI
- B-G500G041043000
- EMDN Code
- P09120399 Bone fixation wires - other
- Device Class
- Class IIb
- Market of Registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- IN-MF-000013665
- Authorised representative
- Amstermed B.V. NL-AR-000001971
Other devices from Sigma Surgical Private Limited
Properties
Other properties (10)
- Sterile: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No