Posture Aid/clavicle Brace
by OPPO Medical Inc. 6 variants
Ref 2075-BG-S, 2175-BG-XXL, 4075-WT-XL, 2175-BG-XS, 2075-BG-XXXL, 2075-BG-XL, 4075-WT-L, 2075-BG-L, 2175-BG-XL, 2075-BG-XXL
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 | Number08402706CL1014K | 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- Withdrawn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 Aid/clavicle BraceClavicle Brace
- Device Name
- Immobilisation Bandages for Shoulder, Arm and Collarbone
- Model / Reference
- 2075-BG-S, 2175-BG-XXL, 4075-WT-XL, 2175-BG-XS, 2075-BG-XXXL, 2075-BG-XL, 4075-WT-L, 2075-BG-L, 2175-BG-XL, 2075-BG-XXL
- Primary DI / UDI-DI
- 00840270602951, 00840270604207, 00840270608465, 00840270604191, 00840270603026, 00840270602982, 00840270608458, 00840270602975, 00840270604184, 00840270603019
- Basic UDI-DI
- 08402706CL1014K
- EMDN Code
- M030501 Immobilisation bandages for shoulder, arm and collarbone
- 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