YuJia
by Shantou Yujia Medical Instrument Co., Ltd. 2 variants
Ref XD1-PYModel XD1-PY,XD2-PY,XD3-PY,XD4-PY,XD5-PY,XD6-PY, XD1-PTY,XD2-PTY,XD3-PTY,XD4-PTY,XD5-PTY,XD6-PTY, XD1-PTY(Z),XD2-PTY(Z),XD3-PTY(Z),XD4-PTY(Z),XD5-PTY(Z),XD6-PTY(Z),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 | Number697722219XD98NC 06977222191110 | Date6 Mar 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- Withdrawn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
- X-Ray Film Illuminator
- Model / Reference
- XD1-PY,XD2-PY,XD3-PY,XD4-PY,XD5-PY,XD6-PY, XD1-PTY,XD2-PTY,XD3-PTY,XD4-PTY,XD5-PTY,XD6-PTY, XD1-PTY(Z),XD2-PTY(Z),XD3-PTY(Z),XD4-PTY(Z),XD5-PTY(Z),XD6-PTY(Z),etc, XD1-PY
- Primary DI / UDI-DI
- 06977222191110
- Basic UDI-DI
- 697722219XD98NC
- EMDN Code
- Z110703 X–ray film viewer
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000040209
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shantou Yujia Medical Instrument Co., Ltd.
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