Taiwan FDA registration 7387c39e058234d6a5e07edb905d771e

"Bistos" Operating headlamp (Non-Sterile)

TW: "必適妥" 手術用頭燈 (未滅菌)

Taiwan·Risk Class 1·MD·BISTOS CO., LTD.·Registered Dec 08, 2015 – Dec 08, 2025Expired

Registration details

Analysis ID: 7387c39e058234d6a5e07edb905d771e
License Form: Ministry of Health Medical Device Import No. 015943
Customs Code: DHA09401594306

Company information

Manufacturer: BISTOS CO., LTD.
Manufacturer Country: Korea, Republic of
Authorized Representative: GOLDENSPRING MEDI-TECH CO., LTD.

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Surgical Headlamps (M.4335)".
Product Type (Level 1): M Ophthalmic devices
Product Type (Level 2): M4335 Surgical headlamp
Import Information: Imported from abroad

Dates and status

Registration Date: Dec 08, 2015
Expiry Date: Dec 08, 2025

About this record

Access comprehensive regulatory information for "Bistos" Operating headlamp (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 7387c39e058234d6a5e07edb905d771e and manufactured by BISTOS CO., LTD.. The authorized representative in Taiwan is GOLDENSPRING MEDI-TECH CO., LTD..

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