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Rollator
EUDAMEDClass I (EU MDR)
Ref SKW7011Model SKW3001、SKW3002、SKW3003、SKW3004、SKW3005、SKW3006、SKW3007、SKW3008、SKW3009、SKW3010、SKW3011、SKW3012、SKW3013, etc
Identity
- Device Name
- ROLLATOR EUDAMED
- Model / Reference
- SKW3001、SKW3002、SKW3003、SKW3004、SKW3005、SKW3006、SKW3007、SKW3008、SKW3009、SKW3010、SKW3011、SKW3012、SKW3013, etc EUDAMEDSKW7011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979436861780 EUDAMED
- Basic UDI-DI
- 697943686ROLLATOR5N 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 Danyang Sunco Machinery 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 | 697943686ROLLATOR5N | Class I | Active |
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Manufacturer
- Manufacturer
- Danyang Sunco Machinery Co.ltd
- EUDAMED SRN
- CN-MF-000051111
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 27564401-41e7-4d52-86cb-123d14d05737 61 fields · synced Jun 19, 2026