Posture Brace
by OPPO Medical Inc. 3 variants
Ref 2356-19.5-GY-S, 2356-19.5-GY-XL, 2356-19.5-GY-M, 2356-23-GY-L, 2275-BG-S, 2356-23-GY-S, 2356-23-GY-M, 2275-BG-XXL, 2275-BG-L
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 | Number08402706CL1044R | Date12 Sep 2024 | 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- Withdrawn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
- Trade Name
- Posture BracePosture Brace with Steel Stay
- Device Name
- Spine OrthosesImmobilisation Bandages for Shoulder, Arm and Collarbone
- Model / Reference
- 2356-19.5-GY-S, 2356-19.5-GY-XL, 2356-19.5-GY-M, 2356-23-GY-L, 2275-BG-S, 2356-23-GY-S, 2356-23-GY-M, 2275-BG-XXL, 2275-BG-L
- Primary DI / UDI-DI
- 00840270614725, 00840270614756, 00840270614732, 00840270614701, 00840270614169, 00840270614688, 00840270614695, 00840270614206, 00840270614183
- Basic UDI-DI
- 08402706CL1044R, 08402706CL1014K
- EMDN Code
- Y060399, M030501
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- US-MF-000005202
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from OPPO Medical Inc.
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: 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