Pure Global
240061
IV
current

Catheters, Vascular, Angioplasty, Balloon, Coronaryๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Šใ€ๅ† ็ŠถๅŠจ่„‰

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

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Šใ€ๅ† ็ŠถๅŠจ่„‰

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
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
BrosMed Medical Co., Ltd
ๅนฟไธœๅš่ฟˆๅŒป็–—็ง‘ๆŠ€่‚กไปฝๆœ‰้™ๅ…ฌๅธ
China
ไธญๅ›ฝ
15th Building, SMEs Venture Park, SongShan Lake Hi-Tech Industrial Development Zone, Dongguan 523808, Guangdong, China
ๆพๅฑฑๆน–้ซ˜ๆ–ฐๆŠ€ๆœฏไบงไธšๅ›ญไธญๅฐไผไธšๅˆ›ไธšๅ›ญ 15 ๅทๆฅผ ๅผ€ๅ‘ๅŒบ, ไธœ่Žž523808, ๅนฟไธœ, ไธญๅ›ฝ
Authorised Representative (AR)
Angeion Medical HK Limited
ๅฎ‰ๅฅๅŒป็–—้ฆ™ๆธฏๆœ‰้™ๅ…ฌๅธ
96886105
Regulatory Timeline
Registration Date
February 19, 2024
Expiry Date
February 18, 2029
Product Models
POT PTCA Balloon Dilatation Catheter (833-2206, 833-3506, 833-2208, 833-3508, 833-2210, 833-3510, 833-2212, 833-3512, 833-2215, 833-3515, 833-2506, 833-3706, 833-2508, 833-3708, 833-2510, 833-3710, 833-2512, 833-3712, 833-2515, 833-3715, 833-2706, 833-4006, 833-2708, 833-4008, 833-2710, 833-4010, 833-2712, 833-4012, 833-2715, 833-4015, 833-3006, 833-4506, 833-3008, 833-4508, 833-3010, 833-4510, 833-3012, 833-4512, 833-3015, 833-4515, 833-3206, 833-5006, 833-3208, 833-5008, 833-3210, 833-5010, 833-3212, 833-5012, 833-3215, 833-5015)
POT PTCA ็ƒๅ›Šๆ‰ฉๅผ ๅฏผ็ฎก(833-2206ใ€833-3506ใ€833-2208ใ€833-3508ใ€833-2210ใ€833-3510ใ€833-2212ใ€833-3512ใ€833-2215ใ€833-3515ใ€833-2506ใ€833-3706ใ€833-2508ใ€833-3708ใ€833-2510ใ€833-3710ใ€833-2512ใ€833-3712ใ€833-2515ใ€833-3715ใ€833-2706ใ€833-4006ใ€8333-4006 -2708ใ€833-4008ใ€833-2710ใ€833-4010ใ€833-2712ใ€833-4012ใ€833-2715ใ€833-4015ใ€833-3006ใ€833-4506ใ€833-3008ใ€833-4508ใ€833-3010ใ€833-4510ใ€833-3012ใ€833-4512ใ€833-3015ใ€833-4515ใ€833-3206ใ€833-5006ใ€833-3208ใ€833-5008ใ€833-3210ใ€833-5010ใ€ 833-3212, 833-5012, 833-3215, 833-5015)