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Rollator
EUDAMEDClass I (EU MDR)
Ref HC0569Model HC0504P HC0503L HC0514 HC0541L HC0561L HC0573 HC0573F HC0574L HC0576 HC0580 HC0509 HC0521W HC0512L HC0502 HC0582 HC0551L HC0561L-1 HC0562L HC0563L HC0564L HC0565L HC0508L HC0588 HC0591L HC0592 HC0594 HC0510L HC0510L-4 HC0510LD-5 HC0512L-1 HC0514LG ,etc
Identity
- Device Name
- Rollator EUDAMED
- Model / Reference
- HC0504P HC0503L HC0514 HC0541L HC0561L HC0573 HC0573F HC0574L HC0576 HC0580 HC0509 HC0521W HC0512L HC0502 HC0582 HC0551L HC0561L-1 HC0562L HC0563L HC0564L HC0565L HC0508L HC0588 HC0591L HC0592 HC0594 HC0510L HC0510L-4 HC0510LD-5 HC0512L-1 HC0514LG ,etc EUDAMEDHC0569 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974809463738 EUDAMED
- Basic UDI-DI
- 697480946Rollator0001ZK EUDAMED
- Direct Marketing DI
- 06974809463738 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
Rollator by Shanghai Humancare Industries 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 | 697480946Rollator0001ZK | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Humancare Industries Co., Ltd
- EUDAMED SRN
- CN-MF-000009765
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a34195fe-28da-43f7-ae72-c82381892bac 61 fields · synced Jun 17, 2026