Taiwan FDA registration 5b1076beaabaf330e5d1b1a7e4f5cfcd

"Heinion" battery-powered retinal lens (unsterilized)

TW: "海尼恩" 電池供電式視網膜鏡 (未滅菌)

Taiwan·Risk Class 1·HEINE OPTOTECHNIK GMBH & CO. KG·Registered Jan 15, 2016 – Jan 15, 2026Expired

Registration details

Analysis ID: 5b1076beaabaf330e5d1b1a7e4f5cfcd
Customs Code: DHA09401607909

Company information

Manufacturer: HEINE OPTOTECHNIK GMBH & CO. KG
Manufacturer Country: Germany
Authorized Representative: DENSO SCIENTIFIC CO., LTD.

Product details

Intended Use: Limited to the classification and grading management of medical equipment "Retinal Scope (M.1780) First Grade Identification Range.
Product Type (Level 1): M Ophthalmology
Product Type (Level 2): M.1780 Retinal Lens
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Jan 15, 2016
Expiry Date: Jan 15, 2026

About this record

Access comprehensive regulatory information for "Heinion" battery-powered retinal lens (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 5b1076beaabaf330e5d1b1a7e4f5cfcd and manufactured by HEINE OPTOTECHNIK GMBH & CO. KG. The authorized representative in Taiwan is DENSO SCIENTIFIC CO., LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.