Taiwan FDA registration a9841728f8b80422271d080a39573655

"Deca" Shimaai pulsed light system

TW: “狄卡”實瑪艾脈衝光系統

Taiwan·Risk Class 2·EL.EN. S.p.A.;; DEKA M.E.L.A. S.r.l.·Registered Dec 04, 2023 – Dec 04, 2028Active

Registration details

Analysis ID: a9841728f8b80422271d080a39573655
Customs Code: DHA05603686904

Company information

Manufacturer: EL.EN. S.p.A.;; DEKA M.E.L.A. S.r.l.
Manufacturer Country: Italy
Authorized Representative: K&C MEDICAL CO., LTD.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4810 Lasers for general surgical, orthopaedic and dermatological use
Import Information: Input;; Contract manufacturing

Dates and status

Registration Date: Dec 04, 2023
Expiry Date: Dec 04, 2028

About this record

Access comprehensive regulatory information for "Deca" Shimaai pulsed light system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a9841728f8b80422271d080a39573655 and manufactured by EL.EN. S.p.A.;; DEKA M.E.L.A. S.r.l.. The authorized representative in Taiwan is K&C MEDICAL CO., LTD..

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