Dual Cone Extractor M14
by Osseointegration International Pty Ltd
Ref OPL-UTK-M14
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number93563710OPL-UTKY4 09356371012212 | Date7 Aug 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Universal Toolkit
- Model / Reference
- OPL-UTK-M14
- Primary DI / UDI-DI
- 09356371012212
- Basic UDI-DI
- 93563710OPL-UTKY4
- Direct Marketing DI
- 09356371012212
- EMDN Code
- Y061280 Lower limb orthoses - accessories
- Device Class
- Class I
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- AU-MF-000014557
- Authorised representative
- Easy Medical Device CommV BE-AR-000011902
Other devices from Osseointegration International Pty Ltd
See all devices from Osseointegration International Pty Ltd →
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- 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