Rollator Walker
by GuangDong Dakseon Medical Device Co., Ltd. EUDAMED
Active
Ref DS9526Model 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 mobility support of individuals with various disabilities. It features a sturdy frame, adjustable straps, and a comfortable seat, making it an ideal solution for those who require assistance with walking or standing. The device is Sterilization Level 0, indicating that it has undergone rigorous cleaning and sterilization procedures to ensure its safety.
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- Withdrawn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, DS9526
- Primary DI / UDI-DI
- 06979127681642
- 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