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upper limb brace
EUDAMEDClass I (EU MDR)
Ref GCSZ-5019Model GCSZ-5000~GCSZ-5049
Identity
- Device Name
- upper limb brace EUDAMED
- Model / Reference
- GCSZ-5000~GCSZ-5049 EUDAMEDGCSZ-5019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977812261698 EUDAMED
- Basic UDI-DI
- 697781226GCSZ001XR EUDAMED
- EMDN Code
- Y061219 CHEST-LUMB-SACRAL-HIP-KNEE-ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
upper limb brace by Guanchi Technology (Hebei) Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697781226GCSZ001XR | Class I | Active |
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Manufacturer
- Manufacturer
- Guanchi Technology (Hebei) Co., Ltd.
- EUDAMED SRN
- CN-MF-000044147
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 05b789ba-0987-41a8-83fd-395ce0d9e650 61 fields · synced Jun 19, 2026