Sheet, Polypropylene, Black [1/4x36x48in]
by Becker Orthopedic Appliance Company United States EUDAMED
Ref Z981028Model 190 EMDN Y060624
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number194545190QF | Date12 Jan 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Lerman Pediatric Shoulder Abduction Rotating Orthosis (SARO)
- Model / Reference
- 190, Z981028
- Primary DI / UDI-DI
- 00194545127107
- Basic UDI-DI
- 194545190QF
- EMDN Code
- Y060624 Shoulder-elbow orthoses
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000004002
- Authorised representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
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 f46f0157-545a-4db0-a72e-2ad0289d3e18