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Rollator
EUDAMEDClass I (EU MDR)
Ref HC0574LModel 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 EUDAMEDHC0574L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974809463110 EUDAMED
- Basic UDI-DI
- 697480946Rollator0001ZK EUDAMED
- Direct Marketing DI
- 06974809463110 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
Rollator by Shanghai Humancare Industries 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 | 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 a61b4925-480c-419c-ae18-6c07e31773ec 61 fields · synced Jun 18, 2026