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lower limb brace
EUDAMEDClass I (EU MDR)
Ref GCXZ-5718Model GCXZ-5700~GCXZ-5749Ref GCXZ-5704Ref GCXZ-5709Ref GCXZ-5710Ref GCXZ-5712Ref GCXZ-5708Ref GCXZ-5716Ref GCXZ-5705Ref GCXZ-5700Ref GCXZ-5706Ref GCXZ-5713
Identity
- Device Name
- lower limb brace EUDAMED
- Model / Reference
- GCXZ-5700~GCXZ-5749 EUDAMEDGCXZ-5718 EUDAMEDGCXZ-5704 EUDAMEDGCXZ-5709 EUDAMEDGCXZ-5710 EUDAMEDGCXZ-5712 EUDAMEDGCXZ-5708 EUDAMEDGCXZ-5716 EUDAMEDGCXZ-5705 EUDAMEDGCXZ-5700 EUDAMEDGCXZ-5706 EUDAMEDGCXZ-5713 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977812262183 EUDAMED06977812262046 EUDAMED06977812262091 EUDAMED06977812262107 EUDAMED06977812262121 EUDAMED06977812262084 EUDAMED06977812262169 EUDAMED06977812262053 EUDAMED06977812262008 EUDAMED06977812262060 EUDAMED06977812262138 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 (11)
- EUDAMED 38edc42d-14d0-4733-b1ff-a9a87019b4af 61 fields · synced Aug 3, 2026
- EUDAMED 73a461ad-aac3-48cf-bdd5-506a25b48d38 61 fields · synced May 16, 2026
- EUDAMED e53b788e-6837-447f-8446-2e7c52af2738 61 fields · synced May 16, 2026
- EUDAMED 727f974f-0544-441b-8b57-99954463baf4 61 fields · synced May 16, 2026
- EUDAMED c7539763-420b-4651-be4f-1fb03fc65c2c 61 fields · synced May 17, 2026
- EUDAMED d7930190-94d2-4219-9d14-3d0910f8a69a 61 fields · synced May 17, 2026
- EUDAMED 89d31740-8a87-434e-9ebb-a3c1f0c8d045 61 fields · synced May 17, 2026
- EUDAMED 42e92f1b-4400-495c-8b10-ec2e309701d6 61 fields · synced May 18, 2026
- EUDAMED 7df4caed-8eff-4446-98d2-7c75711f0357 61 fields · synced May 18, 2026
- EUDAMED 4f5da7c6-9458-471d-9a78-825dac942f1c 61 fields · synced May 18, 2026
- EUDAMED 6f85fefe-e21a-4399-bfc7-c0b28c4187a5 61 fields · synced May 18, 2026