Arm Compression Sleeve
Ref 251Z-BK-L-1, 251Z-RD-XL-1, 251Z-OL-XXXL-1, 251Z-OW-XXL-1, 251Z-BK-XXXL-1, 251Z-OR-XXL-1, 251Z-WT-XXL-1, 251Z-WT-L-1, 251Z-OW-M-1, 251Z-BL-S-1, 251Z-OB-M-1, 251Z-WT-M-1, 251Z-OL-XL-1, 251Z-OW-XL-1, 251Z-OL-M-1, 251Z-BL-L-1, 251Z-OR-M-1, 251Z-BK-S-1, 251Z-WT-XXXL-1, 251Z-OW-XXXL-1, 251Z-OB-XL-1, 251Z-WT-S-1, 251Z-OR-L-1, 251Z-WT-XL-1, 251Z-OW-L-1, 251Z-OB-XXXL-1, 251Z-OR-XXXL-1, 251Z-RD-L-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- Withdrawn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
- 251Z-BK-L-1, 251Z-RD-XL-1, 251Z-OL-XXXL-1, 251Z-OW-XXL-1, 251Z-BK-XXXL-1, 251Z-OR-XXL-1, 251Z-WT-XXL-1, 251Z-WT-L-1, 251Z-OW-M-1, 251Z-BL-S-1, 251Z-OB-M-1, 251Z-WT-M-1, 251Z-OL-XL-1, 251Z-OW-XL-1, 251Z-OL-M-1, 251Z-BL-L-1, 251Z-OR-M-1, 251Z-BK-S-1, 251Z-WT-XXXL-1, 251Z-OW-XXXL-1, 251Z-OB-XL-1, 251Z-WT-S-1, 251Z-OR-L-1, 251Z-WT-XL-1, 251Z-OW-L-1, 251Z-OB-XXXL-1, 251Z-OR-XXXL-1, 251Z-RD-L-1
- Primary DI / UDI-DI
- 04719890065049, 04719890065179, 04719890064998, 04719890064974, 04719890065070, 04719890064967, 04719890065247, 04719890065223, 04719890064851, 04719890065087, 04719890064820, 04719890065216, 04719890064912, 04719890064936, 04719890064837, 04719890065100, 04719890064844, 04719890065025, 04719890065254, 04719890065018, 04719890064905, 04719890065209, 04719890064882, 04719890065230, 04719890064899, 04719890064981, 04719890065001, 04719890065162
- 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