Arm, Hyper, Upper, Left Hand Bend, Medium
by Becker Orthopedic Appliance Company United States EUDAMED
Ref L25M12-LEFTModel Hypers
EMDN Y060309
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number194545HYPERSES | Date13 Jan 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Hyperextension TLSO w/Dot Fastener
- Model / Reference
- Hypers, L25M12-LEFT
- Primary DI / UDI-DI
- 00194545097271
- Basic UDI-DI
- 194545HYPERSES
- EMDN Code
- Y060309 Thoracolumbosacral spine orthoses
- Device Class
- Class I
- 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 & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 6f50bb46-044e-4a61-8700-d8ef9823dc28