upper limb brace
by Guanchi Technology (Hebei) Co., Ltd. EUDAMED
Active
Ref GCSZ-5003Model GCSZ-5000~GCSZ-5049
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697781226GCSZ001XR | Date10 Dec 2024 | 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- Withdrawn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
- GCSZ-5000~GCSZ-5049, GCSZ-5003
- Primary DI / UDI-DI
- 06977812261537
- Basic UDI-DI
- 697781226GCSZ001XR
- EMDN Code
- Y061219 Chest-lumb-sacral-hip-knee-ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000044147
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Guanchi Technology (Hebei) 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