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rollator
EUDAMEDClass I (EU MDR)
Ref GCZX-7000Model GCZX-7000 ~GCZX-7049Ref GCZX-7001Ref GCZX-7018Ref GCZX-7019Ref GCZX-7012Ref GCZX-7003Ref GCZX-7005Ref GCZX-7013Ref GCZX-7015Ref GCZX-7002Ref GCZX-7009
Identity
- Trade Name
- rollator EUDAMED
- Device Name
- rollator EUDAMED
- Model / Reference
- GCZX-7000 ~GCZX-7049 EUDAMEDGCZX-7000 EUDAMEDGCZX-7001 EUDAMEDGCZX-7018 EUDAMEDGCZX-7019 EUDAMEDGCZX-7012 EUDAMEDGCZX-7003 EUDAMEDGCZX-7005 EUDAMEDGCZX-7013 EUDAMEDGCZX-7015 EUDAMEDGCZX-7002 EUDAMEDGCZX-7009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977812263005 EUDAMED06977812263012 EUDAMED06977812263180 EUDAMED06977812263197 EUDAMED06977812263128 EUDAMED06977812263036 EUDAMED06977812263050 EUDAMED06977812263135 EUDAMED06977812263159 EUDAMED06977812263029 EUDAMED06977812263098 EUDAMED
- Basic UDI-DI
- 697781226GCZX001ZQ EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER 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
Category: Walking chair, non-foldable
rollator by Guanchi Technology (Hebei) Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Walking chair, non-foldable.
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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 | 697781226GCZX001ZQ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guanchi Technology (Hebei) Co., Ltd.
- EUDAMED SRN
- CN-MF-000044147
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (11)
- EUDAMED f4f702e5-f42f-4b54-81ad-844b1c3c62b6 61 fields · synced Sep 17, 2026
- EUDAMED 7752b380-2a12-4e96-9174-0f663f498402 61 fields · synced May 16, 2026
- EUDAMED f0ab2f8c-547b-469c-a7cc-afe442b03806 61 fields · synced May 17, 2026
- EUDAMED 33f397b1-769e-404f-b883-5e82cd2708f0 61 fields · synced May 17, 2026
- EUDAMED 3658cbb3-f7cf-4d0a-be42-53e88ccf3ffc 61 fields · synced May 17, 2026
- EUDAMED a71a32fb-5778-4a84-92cf-25319d096f89 61 fields · synced May 18, 2026
- EUDAMED d6b55b3d-7d89-4f5c-8411-52cf0bc77c75 61 fields · synced May 18, 2026
- EUDAMED 676ce9fa-a733-4356-8ed6-19e09390ce9f 61 fields · synced May 19, 2026
- EUDAMED 55620aa6-3db2-4ef1-83c8-0d0d46a38390 61 fields · synced May 19, 2026
- EUDAMED bf31e860-a061-4a6f-a09d-8274b436e0bf 61 fields · synced May 19, 2026
- EUDAMED 740a9f97-29ad-4700-9da0-8c49de5ad689 61 fields · synced May 19, 2026