Auto Phoropter
by Taiyuan North China Xinyuan Tech Center (Co., Ltd) China EUDAMED
Ref AP-800, AP-810, FA-300KP
EMDN Z1212012001
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number101145200800U5 | Date26 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Phoropter
- Model / Reference
- AP-800, AP-810, FA-300KP
- Primary DI / UDI-DI
- 01011452000011, 01011452000028, 06975467342014, 06975467342045, 06975467342021
- Basic UDI-DI
- 101145200800U5, 101145200810U8, 697546734200NK
- Direct Marketing DI
- 0101145200001101011452000028069754673420140697546734204506975467342021
- EMDN Code
- Z1212012001 Visual functional assessment equipment
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000031606
- Authorised representative
- MedPath GmbH DE-AR-000000087
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (5)
- EUDAMED 8b9a1559-8850-47cc-a754-5ad9cb8522a9
- EUDAMED 01011452000028|101145200810U8
- EUDAMED 06975467342014|697546734200NK
- EUDAMED 06975467342045|697546734200NK
- EUDAMED 06975467342021|697546734200NK