240241
IV
current
Catheters, Vascular, Angioplasty, Balloon, Coronaryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Coronary. 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: Catheters, Vascular, Angioplasty, Balloon, Coronary
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
34313
Product Code Detail
34313 Catheters, Vascular, Angioplasty, Balloon, Coronary
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BrosMed Medical Co., Ltd
ๅนฟไธๅ่ฟๅป็็งๆ่กไปฝๆ้ๅ
ฌๅธ
China
ไธญๅฝ
15th Building, SMEs Venture Park, SongShan Lake Hi-Tech Industrial Development Zone, Dongguan, Guangdong, 523808, China
ไธญๅฝๅนฟไธ็ไธ่ๅธๆพๅฑฑๆน้ซๆฐๆๆฏไบงไธๅผๅๅบไธญๅฐไผไธๅไธๅญ15ๅทๆฅผ,523808
Authorised Representative (AR)
DCH Auriga (Hong Kong) Limited
ๅฅฅๅฉไฝณ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
36192800
Regulatory Timeline
Registration Date
July 11, 2024
Expiry Date
July 10, 2029
Product Models
Aperi NC Balloon Dilatation Catheters (442006, 442008, 442010, 442012, 442015, 442018, 442020, 442022, 442025, 442030, 442206, 442208, 442210, 442212, 442215, 442218, 442220, 442222, 442225, 442230, 442506, 442508, 442510, 442512, 442515, 442518, 442520, 442522, 442525, 442530, 442706, 442708, 442710, 442712, 442715, 442718, 442720, 442722, 442725, 442730, 443006, 443008, 443010, 443012, 443015, 443018, 443020, 443022, 443025, 443030, 443206, 443208, 443210, 443212, 443215, 443218, 443220, 443222, 443225, 443230, 443506, 443508, 443510, 443512, 443515, 443518, 443520, 443522, 443525, 443530, 443706, 443708, 443710, 443712, 443715, 443718, 443720, 443722, 443725, 443730, 444006, 444008, 444010, 444012, 444015, 444018, 444020, 444022, 444025, 444030, 444506, 444508, 444510, 444512, 444515, 444518, 444520, 444522, 444525, 444530, 445006, 445008, 445010, 445012, 445015, 445018, 445020, 445022, 445025, 445030)
Aperi NC ็ๅๆฉๅผ ๅฏผ็ฎก (442006, 442008, 442010, 442012, 442015, 442018, 442020, 442022, 442025, 442030, 442206, 442208, 442210, 442212, 442215, 442218, 442220, 442222, 442225, 442230, 442506, 442508, 442510, 442512 442515, , 442518, 442520, 442522, 442525, 442530, 442706, 442708, 442710, 442712, 442715, 442718, 442720, 442722, 442725, 442730, 443006, 443008, 443010, 443012, 443015, 443018, 443020, 443022, 443025, 443030, 443206, 443208, 443210, 443212, 443215, 443218, 443220, 443222, 443225, 443230, 443506, 443508, 443510, 443512, 443515, 443518, 443520, 443522, 443525, 443530, 443706, 443708, 443710, 443712, 443715, 443718, 443720, 443722, 443725, 443730, 444006, 444008, 444010, 444012, 444015, 444018, 444020, 444022, 444025, 444030, 444506, 444508, 444510, 444512, 444515, 444518, 444520, 444522, 444525, 444530, 445006, 445008, 445010, 445012, 445015, 445018, 445020, 445022, 445025, 445030)