Medical Device Division · registration 240379ActiveNIDEK
Hong KongScanning Systems, Optical Coherence Tomography, OphthalmicClass IINIDEK CO., LTD.
Official record identity
- MDACS listing number
- 240379
- Model name
- Optical Coherence Tomography (RS-330)
- Registration date
- September 11, 2024
- Expiry date
- September 10, 2029
- Source update date
- October 16, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
- Published category
- Scanning Systems, Optical Coherence Tomography, Ophthalmic
Official value: II
Published parties
- Registrant / registration holder
- Skyview Optical Company Limited
- Manufacturer
- NIDEK CO., LTD.
Additional source fields
- 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.