Webbing, White, 1in
by Becker Orthopedic Appliance Company United States EUDAMED
Ref Z988133Model 190
EMDN Y061215
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number194545190QF | Date12 Jan 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Lerman Pediatric Shoulder Abduction Rotating Orthosis (SARO)
- Model / Reference
- 190, Z988133
- Primary DI / UDI-DI
- 00194545111892
- Basic UDI-DI
- 194545190QF
- EMDN Code
- Y061215 Hip orthoses (including abduction 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 b631bd43-4d46-475e-b117-ae37fdb05aa8