Rollator
by Sichuan AST Medical Equipment Co., Ltd. Sichuan AST Medical Equipment Co., Ltd. Si Chuan AST 5 variants
Ref 700-979INTModel MA012-60,MS019-60,700-935INT,700-979INT,700-983INT or Customized
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697315617RL001FZ 06973156171334 | Date19 May 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- MA012-60, MS019-60, 700-935INT, 700-979INT, 700-983INT or Customized
- Primary DI / UDI-DI
- 06973156171334
- Basic UDI-DI
- 697315617RL001FZ
- EMDN Code
- Y120606 Wheeled walker
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000001113
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Sichuan AST Medical Equipment Co., Ltd. Sichuan AST Medical Equipment Co., Ltd. Si Chuan AST
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