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Knee walker
EUDAMEDFDA UDIClass I (EU MDR)
Ref HCT-9151Model HCT-9125A,HCT-9125B,HCT-9125AH,HCT-9125C,HCT-9125D,HCT-9125E,HCT-9125G,HCT-9125F,HCT-9129,HCT-9281,HCT-9281B,HCT-9151,HCT-9152,HCT-9152B,HCT-9153,HCT-9150,HCT-9150B,HCT-9154...etc.
Identity
- Trade Name
- HCT FDA UDI
- Generic Name
- Assistive scooter, foot-propelled FDA UDI
- Device Name
- Knee walker EUDAMED
- Model / Reference
- HCT-9125A,HCT-9125B,HCT-9125AH,HCT-9125C,HCT-9125D,HCT-9125E,HCT-9125G,HCT-9125F,HCT-9129,HCT-9281,HCT-9281B,HCT-9151,HCT-9152,HCT-9152B,HCT-9153,HCT-9150,HCT-9150B,HCT-9154...etc. EUDAMEDHCT-9151 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973536542006 EUDAMEDFDA UDI
- Basic UDI-DI
- 697353654kneewalker97 EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y120606 WHEELED WALKER EUDAMED
- GMDN Term
- Assistive scooter, foot-propelled FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3825 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Walking chair, non-foldable
Knee walker by Foshan HCT Medical Equipment Co., ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Walking chair, non-foldable.
- Spanish — Zhenjiang Rapid Rehab & Instrument Co., Ltd. · Class I
- WALKER — CHANGSHA ANWEI ELECTRONIC COMMERCE CO., LTD. · Class I
- AND. KAMALEON KIT/PGO V. ESMER. — FABRICACIONES ORTOPEDICAS ALBACETE, S.L. · Class I
- ROLLATOR — FOSHAN YUFUKANG IMPORT AND EXPORT TRADING LTD · Class I
- WALKER — CHANGSHA ANWEI ELECTRONIC COMMERCE CO., LTD. · Class I
- AND. AIRON ZERO PGO NEGRO — FABRICACIONES ORTOPEDICAS ALBACETE, S.L. · Class I
- Rollator Walker — GuangDong Dakseon Medical Device Co., Ltd. · Class I
- trio B Gehwagen — Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KG · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697353654kneewalker97 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Foshan HCT Medical Equipment Co., ltd
- EUDAMED SRN
- CN-MF-000022837
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 34253fcf-466b-4907-8788-0fe02bb86d0a 61 fields · synced Oct 6, 2026
- FDA UDI a557248f-ca5f-44ad-8d12-ca2fc16d2106 32 fields · synced May 30, 2026