Rollator Walker
by GuangDong Dakseon Medical Device Co., Ltd. EUDAMED
Active
Ref DS9521ZModel DS9501,DS9502,DS9503,DS9504,DS9505,DS9506,DS9507,DS9507A,DS9508,DS9508B,DS9509,DS9509F,DS9510S-6,DS9510S-8,DS9511,DS9512,etc
Overview
The Rollator Walker is a Class I medical device designed for the assistance of individuals with mobility issues. It features a sturdy frame, adjustable legs, and a comfortable seat, making it an ideal option for those who require daily support with walking. This device has undergone rigorous testing to ensure its safety and effectiveness.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697912768RW001RQ | Date8 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- DS9501, DS9502, DS9503, DS9504, DS9505, DS9506, DS9507, DS9507A, DS9508, DS9508B, DS9509, DS9509F, DS9510S-6, DS9510S-8, DS9511, DS9512, etc, DS9521Z
- Primary DI / UDI-DI
- 06979127681581
- Basic UDI-DI
- 697912768RW001RQ
- EMDN Code
- Y120606 Wheeled walker
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000050751
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No