Upper Limb Brace
by Changzhou Pubang Medical Equipment Co., Ltd. EUDAMED
Active
Ref GB-G05Model Phalanx splint：GB-B01、GB-B02、GB-B03 Clavicle fixation band:GB-S01、GB-S02、GB-S03、GB-S04、GB-S05、GB-S06、GB-S07 Shoulder Fixation Strap:GB-J01、GB-J02、GB-J03、GB-J04, etc
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697067603UpperLimbBraceA2 | Date8 Aug 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- Phalanx splint：GB-B01、GB-B02、GB-B03 Clavicle fixation band:GB-S01、GB-S02、GB-S03、GB-S04、GB-S05、GB-S06、GB-S07 Shoulder Fixation Strap:GB-J01、GB-J02、GB-J03、GB-J04, etc, GB-G05
- Primary DI / UDI-DI
- 06970676030547
- Basic UDI-DI
- 697067603UpperLimbBraceA2
- EMDN Code
- Y090699 Devices for body protection - other
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000048852
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Changzhou Pubang Medical Equipment Co., Ltd.
See all devices from Changzhou Pubang Medical Equipment 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