Knee Support
by OPPO Medical Inc. 25 variants
Ref 2920-GY-M, 2920-GY-XL, 1024-BG-F, 1022-BK-XXL, 2523-BG-XL, 2920-GY-XXXXL, 1124-BG-F, 1021-BG-M, 1022-BG-M, 1022-BK-M, RK200-BK-XL, 1021-BK-L, RK101-BK-F, 1021-BG-XL, 1022-BK-S, RK200-BK-S, 2523-BG-L, 2920-GY-S, 2920-GY-XS, 2920-GY-L, RK200-BK-L, 1021-BG-L, 2022-BG-XXL, 2022-BG-XL, 2321-GY-XL, 1023-BG-F, 1021-BG-XXL, RK200-BK-M, 1221-BK-XL, 1021-BK-XL, 2920-GY-XXXL
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 | Number08402706CL1024M | 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- Withdrawn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
- Device Name
- Lower Extremity Orthoses
- Model / Reference
- 2920-GY-M, 2920-GY-XL, 1024-BG-F, 1022-BK-XXL, 2523-BG-XL, 2920-GY-XXXXL, 1124-BG-F, 1021-BG-M, 1022-BG-M, 1022-BK-M, RK200-BK-XL, 1021-BK-L, RK101-BK-F, 1021-BG-XL, 1022-BK-S, RK200-BK-S, 2523-BG-L, 2920-GY-S, 2920-GY-XS, 2920-GY-L, RK200-BK-L, 1021-BG-L, 2022-BG-XXL, 2022-BG-XL, 2321-GY-XL, 1023-BG-F, 1021-BG-XXL, RK200-BK-M, 1221-BK-XL, 1021-BK-XL, 2920-GY-XXXL
- Primary DI / UDI-DI
- 00840270620733, 00840270620757, 00840270600384, 00840270610710, 00840270606379, 00840270620795, 00840270601244, 00840270600308, 00840270600346, 00840270610680, 00840270628265, 00840270610635, 00840270628418, 00840270600322, 00840270609875, 00840270628234, 00840270606362, 00840270620726, 00840270620788, 00840270620740, 00840270628258, 00840270600315, 00840270612721, 00840270601930, 00840270614350, 00840270600377, 00840270610673, 00840270628241, 00840270612264, 00840270610642, 00840270620771
- Basic UDI-DI
- 08402706CL1024M
- EMDN Code
- Y061299 Lower extremity orthoses - other
- 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