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Walker
EUDAMEDClass I (EU MDR)
Ref HK-GY015/WAModel HK-GY014/BC，HK-GY015/WA，HK-GY016/WAP，HK-GY017/TOC
Identity
- Device Name
- Walker EUDAMED
- Model / Reference
- HK-GY014/BC，HK-GY015/WA，HK-GY016/WAP，HK-GY017/TOC EUDAMEDHK-GY015/WA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761138 EUDAMED
- Basic UDI-DI
- 697581676WalkerSD EUDAMED
- EMDN Code
- Y120606 WHEELED WALKER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Walker by Xiamen Huakang Orthopedic 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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- rollator — Guanchi Technology (Hebei) Co., Ltd. · Class I
- Rollator — Caremaster Technology (HK) Group Co., Ltd · Class I
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 | 697581676WalkerSD | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Huakang Orthopedic Co., Ltd
- EUDAMED SRN
- CN-MF-000002290
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED af9112c8-66e2-468c-be5c-c9a23d114ddb 61 fields · synced Jun 18, 2026