Ophtalmology Instruments for Evaluation and Diagnosis - Others
by Chongqing Yeasn Science - Technology Co., Ltd 2 variants
Ref HX4/13Model HX-400
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 | Number697192213400HW 06971922134095 | Date2 Apr 2022 | 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- Withdrawn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
- Pupilometer
- Model / Reference
- HX-400, HX4/13
- Primary DI / UDI-DI
- 06971922134095
- Basic UDI-DI
- 697192213400HW
- Direct Marketing DI
- 06971922134095
- EMDN Code
- Z12120199 Ophtalmology assessments and diagnosis instruments – other
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000012019
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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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