TSM ankle support with stabilization straps and stays, left
by AET Australasian European Trading GmbH
Ref 3181Model ankle orthoses with stabilization straps and stays, prescribable
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 | Number42502394TSM005E6 04250239409112 | Date3 Aug 2023 | 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- Withdrawn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
- TSM ankle support with stabilization straps and stays
- Model / Reference
- ankle orthoses with stabilization straps and stays, prescribable, 3181
- Primary DI / UDI-DI
- 04250239409112
- Basic UDI-DI
- 42502394TSM005E6
- Direct Marketing DI
- 04250239409112
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000009115
Other devices from AET Australasian European Trading GmbH
See all devices from AET Australasian European Trading GmbH →
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