Pure Global
110277
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

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Abbott Vascular
Abbott Vascular
United States
็พŽๅ›ฝ
3200 Lakeside Drive, Santa Clara, California, 95054, USA
3200ๆน–ๆปจๅคง้“, ๅœฃๅ…‹ๆ‹‰ๆ‹‰, ๅŠ ๅˆฉ็ฆๅฐผไบšๅทž, 95054, ็พŽๅ›ฝ
Authorised Representative (AR)
Abbott Medical (Hong Kong) Limited
็พŽๅ›ฝ้›…ๅŸนๅŒป็–—็”จๅ“(้ฆ™ๆธฏ)ๆœ‰้™ๅ…ฌๅธ
29967688
Regulatory Timeline
Registration Date
March 03, 2023
Expiry Date
September 23, 2026
Product Models
NC TREK RX Coronary Dilatation Catheters (1012444-06, 1012444-08, 1012444-12, 1012444-15, 1012444-20, 1012445-06, 1012445-08, 1012445-12, 1012445-15, 1012445-20, 1012446-06, 1012446-08, 1012446-12, 1012446-15, 1012446-20, 1012447-06, 1012447-08, 1012447-12, 1012447-15, 1012447-20, 1012447-25, 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 1012451-15, 1012451-20, 1012451-25, 1012452-08, 1012452-12, 1012452-15, 1012452-20, 1012453-08, 1012453-12, 1012453-15, 1012453-20, 1012454-08, 1012454-12, 1012454-15, 1012454-20, 1012455-08, 1012455-12, 1012455-15, 1012455-20)
NC TREK RX ๅ† ็ŠถๅŠจ่„‰ๆ‰ฉๅผ ๅฏผ็ฎก (1012444-06, 1012444-08, 1012444-12, 1012444-15, 1012444-20, 1012445-06, 1012445-08, 1012445-12, 1012445-15, 1012445-20, 1012446-06, 1012446-08, 1012446-12, 1012446-15, 1012446-20, 1012447-06, 1012447-08, 1012447--08-1012447-12, 1012447-15, 1012447-20, 1012447-25, 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20,1012451-06, 1012451-08, 1012451-12, 1012451-15, 1012451-20, 1012451-25, 1012452-08, 1012452-12, 1012452-15, 1012452-20, 1012453-08, 1012453-12, 1012453-15, 1012453-20, 1012454-08, 1012454-12, 1012454-15, 1012454-20, 1012455-08, 1012455-12, 1012455-15, 1012455-20)