Rollator Walker
by GuangDong Dakseon Medical Device Co., Ltd. EUDAMED
Active
Ref DS9540AModel 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 used for mobility assistance, particularly for individuals with spinal cord injuries or other mobility impairments. It features a sturdy frame, adjustable height and tilt capabilities, and a variety of attachments for different users. This device is designed to provide safe and effective support during daily activities, allowing users to maintain their independence while minimizing strain on the musculoskeletal system.
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- Withdrawn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, DS9540A
- Primary DI / UDI-DI
- 06979127681789
- 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