Medical Device Division · registration 130471ActiveNidek
Hong KongRefractors, Ophthalmic, AutomatedClass IINidek Co., Ltd.
Official record identity
- MDACS listing number
- 130471
- Model name
- ARK-1, ARK-1a, ARK-1s
- Registration date
- November 27, 2023
- Expiry date
- December 27, 2028
- Source update date
- April 18, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Skyview Optical Company Limited
- Manufacturer
- Nidek Co., Ltd.
Official description
Refractors, Ophthalmic, Automated
Additional source fields
- AMD nomenclature code
- 24548
- 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
- Revision number
- b
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.