Joint Unit, Lower, 1/8 x 1/2
by Becker Orthopedic Appliance Company
Ref 1001C82, 1002C82, 1012C82Model 1001, 1002, 1012
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 | Number19454510016N | Date27 Oct 2021 | 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- Withdrawn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
- Trade Name
- Joint Unit, Lower, 1/8 x 1/2Joint Unit, Lower M, 1/8 x 1/2
- Device Name
- Ring Lock Knee JointModified Ring Lock Knee JointPosterior Offset Ring Lock Knee Joint
- Model / Reference
- 1001, 1001C82, 1002, 1002C82, 1012, 1012C82
- Primary DI / UDI-DI
- 00194545063740, 00194545065416, 00194545072094
- Basic UDI-DI
- 19454510016N, 19454510026Q, 19454510126T
- EMDN Code
- Y06121201 Passive knee-ankle-foot orthoses
- 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