Strp Only, Child, SA Std Fl 6in Free Mot
by Becker Orthopedic Appliance Company
Ref 3000-C6FModel Standard Action Ankle Components
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
The Strp Only, Child, SA Std Fl 6in Free Mot device is a reusable, implantable medical device used for ankle stabilization and support. It is designed for pediatric patients and is part of the Becker Orthopedic Appliance Company's line of standard action ankle components.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number194545STDACTANKLEZ9 00194545027339 | Date20 Jan 2022 | 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- Withdrawn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
- Model / Reference
- Standard Action Ankle Components, 3000-C6F
- Primary DI / UDI-DI
- 00194545027339
- Basic UDI-DI
- 194545STDACTANKLEZ9
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000004002
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Becker Orthopedic Appliance Company
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