Strp, Splt, AJT, DA, C, SS, SlSp
by Becker Orthopedic Appliance Company
Ref 2962-C-2Model Double Action Ankle Components
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number194545DBLACTANKLE86 00194545043056 | Date13 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- Withdrawn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
- Double Action Ankle Components
- Model / reference
- Double Action Ankle Components, 2962-C-2
- Primary DI / UDI-DI
- 00194545043056
- Basic UDI-DI
- 194545DBLACTANKLE86
- EMDN code
- Y06120602 Energy return ankle-foot orthoses
- Device class
- Class I
- EU registration type
- Standard device
- 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 (14)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Reusable: No
- Contains latex: No
- Reprocessed single-use device: No
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
- Incorporates a substance derived from human blood or plasma: No
- Contains human tissues or cells: No
- Contains animal tissues or cells: No
- Contains endocrine-disrupting substances: No
- Administering medicine: No
- Measuring function: No
- Incorporates a medicinal substance: No