Pure Global AI
Medical Device Division · registration 230302Active

NIDEK

Hong KongAnalyzers, Physiologic, Visual FunctionClass IINIDEK CO., LTD.
Official record identity
MDACS listing number
230302
Model name
Auto Ref/Kerato/Tono/Pachymeter (TONOREF III)
Registration date
September 14, 2023
Expiry date
September 14, 2028
Source update date
April 12, 2024
Status
Active
Official value: Valid
Classification
Risk class
Class II
Official value: II
Published category
Analyzers, Physiologic, Visual Function
Published parties
Registrant / registration holder
Skyview Optical Company Limited
Manufacturer
NIDEK CO., LTD.
Official description

Analyzers, Physiologic, Visual Function

Additional source fields
AMD nomenclature code
14382
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.