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Medical Device Division · registration 200519Active

NIDEK

Hong KongCameras, Photographic, Ophthalmic, Fundus, Non-MydriaticClass IINIDEK CO. LTD.
Official record identity
MDACS listing number
200519
Model name
Non-Mydriatic Auto Fundus Camera (AFC-330)
Registration date
January 23, 2025
Expiry date
January 04, 2031
Source update date
March 10, 2025
Status
Active
Official value: Valid
Classification
Risk class
Class II
Official value: II
Published category
Cameras, Photographic, Ophthalmic, Fundus, Non-Mydriatic
Published parties
Registrant / registration holder
Skyview Optical Company Limited
Manufacturer
NIDEK CO. LTD.
Official description

Cameras, Photographic, Ophthalmic, Fundus, Non-Mydriatic

Additional source fields
AMD nomenclature code
23486
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
a
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.