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upper limb brace
EUDAMEDClass I (EU MDR)
Ref GCSZ-5005Model GCSZ-5000~GCSZ-5049Ref GCSZ-5009Ref GCSZ-5015Ref GCSZ-5012Ref GCSZ-5008Ref GCSZ-5014Ref GCSZ-5007Ref GCSZ-5003Ref GCSZ-5006Ref GCSZ-5001Ref GCSZ-5018Ref GCSZ-5013
Identity
- Device Name
- upper limb brace EUDAMED
- Model / Reference
- GCSZ-5000~GCSZ-5049 EUDAMEDGCSZ-5005 EUDAMEDGCSZ-5009 EUDAMEDGCSZ-5015 EUDAMEDGCSZ-5012 EUDAMEDGCSZ-5008 EUDAMEDGCSZ-5014 EUDAMEDGCSZ-5007 EUDAMEDGCSZ-5003 EUDAMEDGCSZ-5006 EUDAMEDGCSZ-5001 EUDAMEDGCSZ-5018 EUDAMEDGCSZ-5013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977812261551 EUDAMED06977812261599 EUDAMED06977812261650 EUDAMED06977812261629 EUDAMED06977812261582 EUDAMED06977812261643 EUDAMED06977812261575 EUDAMED06977812261537 EUDAMED06977812261568 EUDAMED06977812261513 EUDAMED06977812261681 EUDAMED06977812261636 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 (12)
- EUDAMED 830cc964-eb57-4a5a-b00b-b84f59a8f77d 61 fields · synced Jul 30, 2026
- EUDAMED d9caab8f-42f7-424f-96e8-29c2d6f477fc 61 fields · synced May 11, 2026
- EUDAMED 006d9106-625b-4f63-a102-095c4c109981 61 fields · synced May 11, 2026
- EUDAMED 3a332a8e-68e6-451d-8c19-a6787934da42 61 fields · synced May 17, 2026
- EUDAMED df1eef97-b9e4-4206-a7fa-cbab2e2a5844 61 fields · synced May 17, 2026
- EUDAMED 54eee7d0-e691-4a07-8be3-b3759889f64d 61 fields · synced May 18, 2026
- EUDAMED 90ed4999-6db8-49c5-a405-acb8149d5b66 61 fields · synced May 18, 2026
- EUDAMED 57d8520c-2b39-4f10-a8c2-3fcd8f9383fd 61 fields · synced May 18, 2026
- EUDAMED b101204a-7e95-4d11-8b78-6f8a1de75f7b 61 fields · synced May 18, 2026
- EUDAMED 8fcc3855-333e-40d4-9f95-eed736f81743 61 fields · synced May 18, 2026
- EUDAMED c6eb1a57-4f9e-465b-828c-cea45f0ffdb6 61 fields · synced May 18, 2026
- EUDAMED ed61ca84-aefe-46bc-a2e2-af558cc36075 61 fields · synced May 18, 2026