Rollator Walker
by GuangDong Dakseon Medical Device Co., Ltd. EUDAMED
Active
Ref DS9519Model DS9501,DS9502,DS9503,DS9504,DS9505,DS9506,DS9507,DS9507A,DS9508,DS9508B,DS9509,DS9509F,DS9510S-6,DS9510S-8,DS9511,DS9512,etc
Overview
For the Rollator Walker, a rollator walker is a medical device designed to assist individuals with mobility issues. This device provides support and stability for users, enabling them to navigate daily tasks with greater ease. The Rollator Walker features advanced ergonomic design, allowing users to sit comfortably while walking.
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- Withdrawn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, DS9519
- Primary DI / UDI-DI
- 06979127681529
- 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