Elbow Compression Sleeve
Ref 250Z-BL-M-1, 250Z-OW-L-1, 250Z-BL-XXL-1, 250Z-RD-L-1, 250Z-OB-L-1, 250Z-BL-S-1, 250Z-OB-XL-1, 250Z-BK-L-1, 250Z-BK-S-1, 250Z-OW-M-1, 250Z-RD-XXXL-1, 250Z-RD-M-1, 250Z-BK-XXL-1, 250Z-BK-M-1, 250Z-OL-XL-1, 250Z-WT-XXL-1, 250Z-OB-M-1, 250Z-OR-L-1, 250Z-WT-M-1, 250Z-WT-XL-1, 250Z-WT-XXXL-1, 250Z-WT-S-1, 250Z-OW-XXXL-1, 250Z-OL-S-1, 250Z-OL-XXXL-1, 250Z-BL-L-1, 250Z-BL-XXXL-1
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 | Number471988489CL103GL | Date4 Sep 2023 | 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- Withdrawn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
- Upper Extremity Orthoses
- Model / Reference
- 250Z-BL-M-1, 250Z-OW-L-1, 250Z-BL-XXL-1, 250Z-RD-L-1, 250Z-OB-L-1, 250Z-BL-S-1, 250Z-OB-XL-1, 250Z-BK-L-1, 250Z-BK-S-1, 250Z-OW-M-1, 250Z-RD-XXXL-1, 250Z-RD-M-1, 250Z-BK-XXL-1, 250Z-BK-M-1, 250Z-OL-XL-1, 250Z-WT-XXL-1, 250Z-OB-M-1, 250Z-OR-L-1, 250Z-WT-M-1, 250Z-WT-XL-1, 250Z-WT-XXXL-1, 250Z-WT-S-1, 250Z-OW-XXXL-1, 250Z-OL-S-1, 250Z-OL-XXXL-1, 250Z-BL-L-1, 250Z-BL-XXXL-1
- Primary DI / UDI-DI
- 04719890064608, 04719890064417, 04719890064639, 04719890064677, 04719890064387, 04719890064592, 04719890064424, 04719890064561, 04719890064547, 04719890064370, 04719890064707, 04719890064660, 04719890064585, 04719890064554, 04719890064431, 04719890064752, 04719890064349, 04719890064400, 04719890064721, 04719890064745, 04719890064769, 04719890064714, 04719890064530, 04719890064301, 04719890064516, 04719890064615, 04719890064646
- Basic UDI-DI
- 471988489CL103GL
- EMDN Code
- Y060699 Orthoses, upper extremity - other
- Device Class
- Class I
- EU market of registration
- Malta
Manufacturer details
- EUDAMED SRN
- TW-MF-000005197
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Welsheng Corp.
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