210313
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)
Biotronik AG
Biotronik Ag
Switzerland
็ๅฃซ
Ackerstrasse 6, 8180 Bรผlach, Switzerland
Ackerstrasse 6, 8180 Bรผlach, ็ๅฃซ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
31904500
Regulatory Timeline
Registration Date
September 03, 2021
Expiry Date
September 03, 2026
Product Models
Pantera LEO Fast-Exchange PTCA Catheter (366991, 366992, 366993, 366994, 366995, 366996, 366997, 366998, 366999, 367000, 367001, 367002, 367003, 367004, 367005, 367006, 367007, 367008, 367009, 367010, 367011, 367012, 367013, 367014, 367015, 367016, 367017, 367018, 367019, 367020, 367021, 367022, 367023, 367024, 367025, 367026, 367027, 367028, 367029, 367030, 367031, 367032, 367033, 367034, 367035, 367036, 367037, 367038, 367039, 367040, 367041, 367042, 367043, 367044, 367045)
Pantera LEO ๅฟซ้็ฝฎๆข PTCA ๅฏผ็ฎก (366991, 366992, 366993, 366994, 366995, 366996, 366997, 366998, 366999, 367000, 367001, 367002, 367003, 367004, 367005, 367006, 367007, 367008, 367009, 367010, 367011, 367012, 367013, 367014, , , 367015, , 367016, 367017, 367018, 367019, 367020, 367021, 367022, 367023, 367024, 367025, 367026, 367027, 367028, 367029, 367030, 367031, 367032, 367033, 367034, 367035, 367036, 367037, 367038, 367039, 367040, 367041, 367042, 367043, 367044, 367045)