manual wheelchair
by Shandong Guyue Healthcare Appliance Co., Ltd
Ref SYIV100-GY-A2Model SYIV100-GY-A2, SYIV100-GY-A1, SYIV100-GY-A3, XH705T, GY909L, GY965LH, GY967LHB-20, GY9866L, GY-SDLY-001, GY-SDLY-002, GY-SDLY-003, GY-SDLY-004, GY-SDLY-005, GY-SDLY-006, etc
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 | Number697684969SDLY001GM 06976849692505 | Date12 Jun 2024 | 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- Withdrawn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
- Device Name
- manual wheelchair
- Model / Reference
- SYIV100-GY-A2, SYIV100-GY-A1, SYIV100-GY-A3, XH705T, GY909L, GY965LH, GY967LHB-20, GY9866L, GY-SDLY-001, GY-SDLY-002, GY-SDLY-003, GY-SDLY-004, GY-SDLY-005, GY-SDLY-006, etc
- Primary DI / UDI-DI
- 06976849692505
- Basic UDI-DI
- 697684969SDLY001GM
- EMDN Code
- Y122103 Push wheelchairs
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000009844
- 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