Plastic, Natural, LDPE [1/8 X 32 X 48in]
by Becker Orthopedic Appliance Company
Ref Z981079Model 190
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 | Number194545190QF 00194545173098 | Date12 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- Withdrawn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
- Lerman Pediatric Shoulder Abduction Rotating Orthosis (SARO)
- Model / Reference
- 190, Z981079
- Primary DI / UDI-DI
- 00194545173098
- Basic UDI-DI
- 194545190QF
- EMDN Code
- Y060624 Shoulder-elbow 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