Pure Global
180284

Occluders, Vascular, Intravascular Embolization, Coil

封堵器,血管,血管内栓塞,线圈
Balt USA, LLC.·IV·Hong Kong MDACS·Registered August 21, 2018
Device overview
Risk class
IV
Product code
22543
State
Expired.
Status
N/A
Product code detail
22543 Occluders, Vascular, Intravascular Embolization, Coil
Manufacturer (製造商)
Name
Balt USA, LLC.
Balt Usa,Llc
Country
United States
美国
Address
29 Parker, Irvine, CA 92618, United States of America
29 帕克, 尔湾, CA 92618, 美国
Authorised representative (AR)
Name
Raritan Science Trading Limited
瑞敦科贸有限公司
Phone
34695685
Regulatory timeline
Registration date
August 21, 2018
Expiry date
August 21, 2023
Product models
Optima Coil System (Complex - 10 Standard(OPTI0517CST10, OPTI0611CST10, OPTI0620CST10, OPTI0713CST10, OPTI0724CST10, OPTI0816CST10, OPTI0827CST10, OPTI0923CST10, OPTI0930CST10, OPTI1027CST10, OPTI1034CST10), Complex - 10 Soft(OPTI0203CSF10, OPTI0204CSF10, OPTI0206CSF10, OPTI0208CSF10, OPTI0255CSF10, OPTI0306CSF10, OPTI0308CSF10, OPTI0310CSF10, OPTI0407CSF10, OPTI0413CSF10, OPTI0509CSF10, OPTI0517CSF10, OPTI0611CSF10, OPTI0620CSF10, OPTI0713CSF10, OPTI0724CSF10, OPTI0816CSF10, OPTI0827CSF10), Complex - 10 Super Soft(OPTI0101CSS10, OPTI0102CSS10, OPTI0103CSS10, OPTI0104CSS10, OPTI0152CSS10, OPTI0153CSS10, OPTI0154CSS10, OPTI0202CSS10, OPTI0203CSS10, OPTI0204CSS10, OPTI0206CSS10, OPTI0208CSS10, OPTI0253CSS10, OPTI0254CSS10, OPTI0256CSS10, OPTI0304CSS10, OPTI0306CSS10, OPTI0308CSS10, OPTI0310CSS10, OPTI0356CSS10, OPTI0358CSS10, OPTI0406CSS10, OPTI0408CSS10, OPTI0410CSS10, OPTI0508CSS10, OPTI0510CSS10, OPTI0513CSS10), Helical - 10 Standard(OPTI0615HST10, OPTI0620HST10, OPTI0720HST10, OPTI0730HST10, OPTI0820HST10, OPTI0830HST10, OPTI0930HST10, OPTI1030HST10), Helical - 10 Soft(OPTI0304HSF10, OPTI0306HSF10, OPTI0308HSF10, OPTI0310HSF10, OPTI0406HSF10, OPTI0408HSF10, OPTI0410HSF10, OPTI0506HSF10, OPTI0508HSF10, OPTI0510HSF10, OPTI0606HSF10, OPTI0608HSF10, OPTI0610HSF10), Helical - 10 Super Soft(OPTI0101HSS10, OPTI0102HSS10, OPTI0103HSS10, OPTI0104HSS10, OPTI0151HSS10, OPTI0152HSS10, OPTI0153HSS10, OPTI0154HSS10, OPTI0201HSS10, OPTI0202HSS10, OPTI0203HSS10, OPTI0204HSS10, OPTI0206HSS10, OPTI0208HSS10, OPTI0253HSS10, OPTI0254HSS10, OPTI0256HSS10, OPTI0304HSS10, OPTI0306HSS10, OPTI0308HSS10, OPTI0310HSS10, OPTI0406HSS10, OPTI0408HSS10, OPTI0410HSS10, OPTI0506HSS10, OPTI0508HSS10, OPTI0510HSS10), Complex 18(OPTI0620COM18, OPTI0724COM18, OPTI0827COM18, OPTI0930COM18, OPTI1034COM18, OPTI1137COM18, OPTI1240COM18, OPTI1343COM18, OPTI1447COM18, OPTI1550COM18, OPTI1655COM18, OPTI1860COM18, OPTI2065COM18, OPTI2265COM18, OPTI2465COM18)
Optima 线圈系统(复杂 - 10 标准(OPTI0517CST10、OPTI0611CST10、OPTI0620CST10、OPTI0713CST10、OPTI0724CST10、OPTI0816CST10、OPTI0827CST10、OPTI0923CST10、OPTI0930CST10、OPTI1027CST10、OPTI1034CST10)、复杂 - 10 软(OPTI0203CSF10、OPTI0204CSF10、OPTI0206CSF10、OPTI0208CSF10、OPTI0255CSF10、OPTI0306CSF10、OPTI0308CSF10、OPTI0310CSF10、OPTI0407CSF10、OPTI0413CSF10、OPTI0509CSF10、OPTI0517CSF10、OPTI0611CSF10、OPTI0620CSF10、OPTI0713CSF10、OPTI0724CSF10、OPTI0816CSF10,OPTI0827CSF10), 复杂 - 10 超软(OPTI0101CSS10、OPTI0102CSS10、OPTI0103CSS10、OPTI0104CSS10、OPTI0152CSS10、OPTI0153CSS10、OPTI0154CSS10、OPTI0202CSS10、OPTI0203CSS10、OPTI0204CSS10、OPTI0206CSS10、OPTI0208CSS10、OPTI0253CSS10、OPTI0254CSS10、OPTI0256CSS10、OPTI0304CSS10、OPTI0306CSS10、OPTI0308CSS10、OPTI0310CSS10、OPTI0356CSS10、OPTI0358CSS10、OPTI0406CSS10、OPTI0408CSS10、OPTI0410CSS10、OPTI0508CSS10、OPTI0510CSS10、OPTI0513CSS10)、螺旋 - 10 标准(OPTI0615HST10,OPTI0620HST10、OPTI0720HST10、OPTI0730HST10、OPTI0820HST10、OPTI0830HST10、OPTI0930HST10、OPTI1030HST10)、螺旋 - 10 软(OPTI0304HSF10、OPTI0306HSF10、OPTI0308HSF10、OPTI0310HSF10、OPTI0406HSF10、OPTI0408HSF10、OPTI0410HSF10、OPTI0506HSF10、OPTI0508HSF10、OPTI0510HSF10、OPTI0606HSF10、OPTI0608HSF10、OPTI0610HSF10)、螺旋 - 10 超软(OPTI0101HSS10、OPTI0102HSS10、OPTI0103HSS10、OPTI0104HSS10、OPTI0151HSS10、OPTI0152HSS10、OPTI0153HSS10、OPTI0154HSS10、OPTI0201HSS10、OPTI0202HSS10, OPTI0203HSS10, OPTI0204HSS10, OPTI0206HSS10, OPTI0208HSS10, OPTI0253HSS10, OPTI0254HSS10, OPTI0256HSS10, OPTI0304HSS10, OPTI0306HSS10, OPTI0308HSS10, OPTI0310HSS10, OPTI0406HSS10, OPTI0408HSS10, OPTI0410HSS10, OPTI0506HSS10, OPTI0508HSS10, OPTI0510HSS10), 复合物 18(OPTI0620COM18, OPTI0724COM18, OPTI0827COM18, OPTI0930COM18, OPTI1034COM18, OPTI1137COM18, OPTI1240COM18, OPTI1343COM18, OPTI1447COM18, OPTI1550COM18, OPTI1655COM18, OPTI1860COM18, OPTI2065COM18,OPTI2265COM18,OPTI2465COM18)
About this record

This profile provides complete Hong Kong MDACS registration information for Occluders, Vascular, Intravascular Embolization, Coil. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Occluders, Vascular, Intravascular Embolization, Coil

產品資訊： 封堵器,血管,血管内栓塞,线圈