Locking Lever, 9005
by Becker Orthopedic Appliance Company
Ref 9005A65Model 9005
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
Discover the Locking Lever, 9005 medical device from Becker Orthopedic Appliance Company. This innovative product is designed to provide secure and reliable locking mechanisms for various medical implants and devices, ensuring patient safety and comfort. With its advanced features and rigorous testing protocols, this device is ideal for professional use in healthcare settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number19454590058N 00194545092375 | Date18 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- Withdrawn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
- Device Name
- SafetyStride
- Model / Reference
- 9005, 9005A65
- Primary DI / UDI-DI
- 00194545092375
- Basic UDI-DI
- 19454590058N
- EMDN Code
- Y06121202 Energy return orthoses for knee-ankle-foot
- Device Class
- Class I
- EU market of registration
- Germany
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