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lower limb brace
EUDAMEDClass I (EU MDR)
Ref GCXZ-5703Model GCXZ-5700~GCXZ-5749
Identity
- Device Name
- lower limb brace EUDAMED
- Model / Reference
- GCXZ-5700~GCXZ-5749 EUDAMEDGCXZ-5703 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977812262039 EUDAMED
- Basic UDI-DI
- 697781226GCXZ001ZG 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
lower 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 | 697781226GCXZ001ZG | 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 2f299f11-07ac-4bf1-82f0-1207f0ffaf12 61 fields · synced Jun 18, 2026