Medical Device Division · registration 240403ActiveNIDEK CO., LTD.
Hong KongScanning Systems, Laser, Optical Coherence Tomography, Ophthalmic, BiometryClass IINIDEK CO., LTD.
Official record identity
- MDACS listing number
- 240403
- Model name
- Optical Biometer (AL-Scan)
- Registration date
- September 24, 2024
- Expiry date
- September 23, 2029
- Source update date
- November 05, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
- Published category
- Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic, Biometry
Official value: II
Published parties
- Registrant / registration holder
- Skyview Optical Company Limited
- Manufacturer
- NIDEK CO., LTD.
Official description
Scanning Systems, Laser, Optical Coherence Tomography, Ophthalmic, Biometry
Additional source fields
- AMD nomenclature code
- 23549
- Traditional Chinese local responsible person
- 視佳光學有限公司
- Local responsible person phone
- 29590077
- Published manufacturer address
- 34-14 Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.