Neoprene Shoulder Support
by e-life International Co., Ltd. 10 variants
Ref MSHNP01 (L/UNI/BK), MSHNP01 (XL/UNI/BK), MSHNP01 (L/UNI/GY), MSHNP01 (S/UNI/BK), MSHNP01 (XL/UNI/BG), MSHNP01 (2XL/UNI/GY), MSHNP01 (S/Right/BG), MSHNP01 (M/Right/BG), MSHNP01 (M/UNI/GY), MSHNP01 (L/Right/BG), MSHNP01 (2XL/UNI/BK), MSHNP01 (XL/Right/BG), MSHNP01 (L/Left/BG), MSHNP01 (XL/UNI/GY), MSHNP01 (S/UNI/BG), MSHNP01 (XL/Left/BG)Model Shoulder Brace Series
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 | Number471230298SHRG | Date30 Apr 2026 | 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- Withdrawn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
- Shoulder strap orthosis and tubular support bandage
- Model / Reference
- Shoulder Brace Series, MSHNP01 (L/UNI/BK), MSHNP01 (XL/UNI/BK), MSHNP01 (L/UNI/GY), MSHNP01 (S/UNI/BK), MSHNP01 (XL/UNI/BG), MSHNP01 (2XL/UNI/GY), MSHNP01 (S/Right/BG), MSHNP01 (M/Right/BG), MSHNP01 (M/UNI/GY), MSHNP01 (L/Right/BG), MSHNP01 (2XL/UNI/BK), MSHNP01 (XL/Right/BG), MSHNP01 (L/Left/BG), MSHNP01 (XL/UNI/GY), MSHNP01 (S/UNI/BG), MSHNP01 (XL/Left/BG)
- Primary DI / UDI-DI
- 04719894921693, 04719894921716, 04719894921709, 04719894921655, 04712302988820, 04719894921761, 04712302988752, 04712302988769, 04719894921686, 04712302988776, 04719894921754, 04712302988783, 04710374236535, 04719894921723, 04712302988790, 04710374236542
- Basic UDI-DI
- 471230298SHRG
- EMDN Code
- Y060621 Shoulder orthoses
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000009901
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from e-life International Co., Ltd.
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