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Rollator
EUDAMEDClass I (EU MDR)
Ref SKW3013Model 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 EUDAMEDSKW3013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979436861599 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
Rollator by Danyang Sunco Machinery 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 | 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 6f5c489a-6ed7-4cd2-94cc-407db9ca125e 61 fields · synced Jun 18, 2026