Upper Limb Brace
by Zhejiang Steriger Sports Medicine Technology Co., Ltd. EUDAMED
Active
Ref BDFP-8214Model Arm sleeve（SME-02、48724、48725） Wrist support（BDFP-8214、48712、48713、BDFP-10、02578） Elbow support（BDFE-14、46790）etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697431877ULB001PG | Date16 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Upper Limb Brace
- Model / Reference
- Arm sleeve（SME-02、48724、48725） Wrist support（BDFP-8214、48712、48713、BDFP-10、02578） Elbow support（BDFE-14、46790）etc, BDFP-8214
- Primary DI / UDI-DI
- 06974318770204
- Basic UDI-DI
- 697431877ULB001PG
- EMDN Code
- Y060699 Orthoses, upper extremity - other
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000048245
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Zhejiang Steriger Sports Medicine Technology 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