Pure Global
90279
IV
current

Catheters, Vascular, Guiding, Coronary Arteryๅฏผ็ฎกใ€่ก€็ฎกๅฏผ็ฎกใ€ๅฏผ็ฎกใ€ๅ† ็ŠถๅŠจ่„‰

This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Guiding, Coronary Artery. 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, Guiding, Coronary Artery

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎกใ€่ก€็ฎกๅฏผ็ฎกใ€ๅฏผ็ฎกใ€ๅ† ็ŠถๅŠจ่„‰

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18674
Product Code Detail
18674 Catheters, Vascular, Guiding, Coronary Artery
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United States
็พŽๅ›ฝ
14201 North West 60th Avenue, Miami Lakes, Florida, 33014 USA
14201่ฅฟๅŒ—60thๅคง้“, ่ฟˆ้˜ฟๅฏ†ๆน–ๅŒบ, ไฝ›็ฝ—้‡Œ่พพๅทž, 33014 ็พŽๅ›ฝ
Authorised Representative (AR)
Emergo Hong Kong Limited
ๅŸƒ้ป˜้ซ˜้ฆ™ๆธฏๆœ‰้™ๅ…ฌๅธ
22769196
Regulatory Timeline
Registration Date
July 23, 2024
Expiry Date
July 22, 2029
Product Models
Vista Brite Tip Guiding Catheters (5560020L, 5560040L, 5560080L, 5560400L, 5560540L, 5560560L, 5560600L, 5560800L, 5560820L, 5561120L, 5561620L, 5561680L, 5561720L, 5560700L, 5561740L, 5561900L, 5562700L, 5562780L, SM7329, SM7328, SM7331, SM7332, SM7330, SM7333, SM7327, 67000000, 67000200, 67000300, 67000400, 6700040E, 67000490, 67000500, 67000600, 67000800, 67001000, 67001200, 67001400, 67001600, 67002600, 67002700, 67002800, 67002900, 67003400, 67003500, 67003600, 67003700, 67003800, 67004000, 67004100, 67004200, 67004400, 67004800, 67005200, 67005300, 67005400, 6700540E, 67005490, 67005500, 67005600, 67005700, 67005800, 67005900, 67006000, 67006100, 67006200, 67006300, 67006400, 67006500, 67006600, 67006700, 67007000, 67007100, 67007200, 67007300, 67007400, 67007500, 67007600, 67007700, 67008000, 67008100, 67008200, 6700820E, 67008255, 67008290, 67008300, 67008400, 67009000, 67009800, 67009900, 67011000, 67011100, 67011200, 67011300, 67012000, 67012100, 67012200, 67012300, 67012400, 67012500, 67012600, 67012700, 67013000, 67013100, 67016200, 67016400, 67016600, 67016800, 67017000, 67017200, 67017400, 67018000, 67018090, 67018100, 67018200, 67018290, 67018300, 67018800, 67019000, 67019055, 67019090, 67019100, 67019200, 67019300, 67021055, 67021255, 67021455, 67021890, 67025400, 67025490, 67027000, 67027055, 67027090, 67027100, 67027200, 67027800, 67027855, 67027890, 67027900, 67028055, 67028090, 6700040L, 6700400L, 6700540L, 6700820L, 6701100L, 6701120L, 6702700L, 6702780L, 77800000, 77800100, 77800200, 7780020E, 77800290, 77800300, 77800400, 7780040E, 77800490, 77800500, 7780050E, 77800600, 77800700, 77800800, 77800900, 77801000, 77801200, 77801300, 77801400, 77801500, 77801600, 77801800, 77802200, 77803400, 7780360E, 77803690, 77803600, 77803700, 77803800, 77803900, 77804000, 77804090, 77804100, 77804200, 77804300, 77804400, 77804500, 77804800, 77804900, 77805200, 77805300, 77805400, 77805500, 77805600, 77805700, 77805800, 77805900, 77806000, 77806100, 77806200, 77806300, 77806400, 77806500, 77808000, 77808100, 77808200, 7780820E, 77808290, 77808300, 7780830E, 77808390, 77808400, 77808500, 77808800, 77808900, 77809000, 77809100, 77809200, 77811000, 77811090, 77811100, 77811200, 77811300, 77811400, 77811600, 77811800, 77818000, 77818090, 77818100, 77818200, 77818300, 77818800, 77819000, 77819090, 77819100, 77819190, 77821055, 77821255, 77821455, 77821690, 77822255, 77822455, 77825090, 77827000, 77827055, 77827090, 77827100, 77827200, 77827300, 77827800, 77827855, 77827890, 77827900, 77827990, 77828055, 77828090, 588800, 588801, 588802, 588803, 588804, 588805, 588806, 588809, 588810, 588811, 588812, 588813, 588815, 588815T, 588816, 588816T, 588817, 588818, 588819, 588820, 588821, 588822, 588823, 588823E, 588823T, 588824, 588825, 588825E, 588826, 588827, 588828, 588829, 588830, 588830E, 588830T, 588831, 588831E, 588831T, 588832, 588833, 588834, 588835, 588836, 588837, 588838, 588839, 588840, 588841, 5888102, 5888110, 5888201, 5888207, 588840P, 588841P, 588841T, 588842, 588842P, 588843, 588843E, 588843P, 588843T, 588844, 588844E, 588844P, 588844T, 588845, 588845P, 588845T, 588846, 588847, 588847P, 588848, 588849, 588849P, 588850, 588850T, 588851, 588851E, 588851T, 588852, 588853, 588853E, 588854, 588855, 588856, 588868, 588857, 588858, 588858P, 588859, 588860, 588861, 588862, 588863, 588864, 588865, 588866, 588867, 588870, 588871, 588872, 588873, 588874, 588875, 588876, 588877, 588878, 588879, 588880, 588882, 588883, 588885, 588886, 588887, 588889, 588890, 588891, 588892, 588893, 588894, 588895, 588896, 588898, 588899, 5888100, 5888101, 5888103, 5888104, 5888105, 5888106, 5888107, 5888108, 5888109, 5888111, 5888112, 5888113, 5888114, 5888115, 5888116, 5888200, 5888202, 5888206, 588834E, 588846P, 588848E, 588857P, 588884, 588892T, 598900, 598909, 598910, 598915, 598916, 598925, 598917, 598918, 598919, 598920, 598923, 598928, 598930, 598931, 598932, 598933, 598934, 598936, 598937, 598941, 598941P, 598942, 598942P, 598943, 598943P, 598944, 598944P, 598945, 598945P, 598946P, 598947, 598948, 598949, 598949P, 598950, 598951, 598952, 598953, 598955, 598966, 598978, 598986, 598987, 598991, 598992, 598994, 598995, 598996, 598997, 5989200, 5989201, 5989202, 5989206, 5989207, 511011, 511012, 511014, 511015, 511016, 511030, 511031, 511032, 511034, 511036, 5110200, 5110202, 511040P, 511049, 511050, 5110201, 5110206, 5110207)
Vista Briteๅฐ–็ซฏๅฏผๅฐฟ็ฎก(5560020Lใ€5560040Lใ€5560080Lใ€5560400Lใ€5560540Lใ€5560560Lใ€5560600Lใ€5560800Lใ€5560820Lใ€5561120Lใ€5561620Lใ€5561680Lใ€5561720Lใ€5560700Lใ€5561740Lใ€5561900Lใ€5562700Lใ€5562780Lใ€SM7 3 29, SM7328, SM7331, SM7332, SM7330, SM7333, SM7327, 67000000, 67000200, 67000300, 67000400, 6700040E, 67000490, 67000500, 67000600, 67000800, 67001000, 67001200, 67001400, 67001600, 67002600, 67002700, 67002800, 67002900, 67003400, 67003500, 67003600, 67003700, 67003800, 67004000, 67004100, 67004200, 67004400, 67004800, 67005200, 67005300, 67005400, 6700540E, 67005490, 67005500, 67005600, 67005700, 67005800, 67005900, 67006000, 67006100, 67006200, 67006300, 67006400, 67006500, 67006600, 67006700, 67007000, 67007100, 67007200, 67007300, 67007400, 67007500, 67007600, 67007700, 67008000, 67008100, 67008200, 6700820E, 67008255, 67008290, 67008300, 67008400, 67009000, 67009800, 67009900, 67011000, 67011100, 67011200, 67011300, 67012000, 67012100, 67012200, 67012300, 67012400, 67012500, 67012600, 67012700, 67013000, 67013100, 67016200, 67016400, 67016600, 67016800, 67017000, 67017200, 67017400, 67018000, 67018090, 67018100, 67018200, 67018290, 67018300, 67018800, 67019000, 67019055, 67019090, 67019100, 67019200, 67019300, 67021055, 67021255, 67021455 , , , , , , , , 67021890, 67025400, 67025490, 67027000, 67027055, 67027090, 67027100, 67027200, 67027800, 67027855, 67027890, 67027900, 67028055, 67028090, 6700040L, 6700400L, 6700540L, 6700820L, 6701100L, 6701120L, 6702700L, 6702780L, 77800000, 77800100, 77800200, 7780020E, 77800290, 77800300, 77800400, 7780040E, 77800490, 77800500, 7780050E, 77800600, 77800700, 77800800, 77800900, 77801000, 77801200, 77801300, 77801400, 77801500, 77801600, 77801800, 77802200, 77803400, 77 80360E, 77803690, 77803600, 77803700, 77803800, 77803900, 77804000, 77804090, 77804100, 77804200, 77804300, 77804400, 77804500, 77804800, 77804900, 77805200, 77805300, 77805400, 77805500, 77805600, 77805700, 77805800, 77805900, 77806000, 77806100, 77806200, 77806300, 77806400, 77806500, 77808000, 77808100, 77808200, 7780820E, 77808290, 77808300, 7780830E, 77808390, 77808400, 77808500, 77808800, 77808900, 77809000, 77809100, 77809200, 77811000, 77811090, 77811100, 77811200, 77811300, 77811400 77811600, , , 77811800, 77818000, 77818090, 77818100, 77818200, 77818300, 77818800, 77819000, 77819090, 77819100, 77819190, 77821055, 77821255, 77821455, 77821690, 77822255, 77822455, 77825090, 77827000, 77827055, 77827090, 77827100, 77827200, 77827300, 77827800, 77827855, 77827890, 77827900, 77827990, 77828055, 77828090, 588800, 588801, 588802, 588803, 588804, 588805, 588806, 588809, 588810, 588811, 588812, 588813, 588815, 588815T, 588816, 588816T, 588817, 588818, 588819, 588820, 588821, 588822, 588823, 5888 8823E, 588823T, 588824, 588825, 588825E, 588826, 588827, 588828, 588829, 588830, 588830E, 588830T, 588831, 588831E, 588831T, 588832, 588833, 588834, 588835, 588836, 588837, 588838, 588839, 588840, 588841, 5888102, 5888110, 5888201, 5888207, 588840P, 588841P, 588841T, 588842, 588842P, 588843, 588843E, 588843P, 588843T, 588844, 588844E, 588844P, 588844T, 588845, 588845P, 588845T, 588846, 588847, 588847P, 588848, 588849, 588849P, 588850, 5888850, 58888450 850T, 588851, 588851E, 588851T, 588852, 588853, 588853E, 588854, 588855, 588856, 588868, 588857, 588858, 588858P, 588859, 588860, 588861, 588862, 588863, 588864, 588865, 588866, 588867, 588870, 588871, 588872, 588873, 588874, 588875, 588876, 588877, 588878, 588879, 588880, 588882, 588883, 588885, 588886, 588887, 588889, 588890, 588891, 588892, 588893, 588894, 588895, 588896, 588898, 588899, 5888100, 5888101, 5888103, 5888104, 5888105, 5888106, 5888107, 5888108, 5888109, 5888111, 5888112, 5888113, 5888114, 5888115, 5888116, 5888200, 5888202, 5888206, 588834E, 588846P, 588848E, 588857P, 588884, 588892T, 598900, 598909, 598910, 598915, 598916, 598925, 598917, 598918, 598919, 598920, 598923, 598928, 598930, 598931, 598932, 598933, 598934, 598936, 598937, 598941, 598941P, 598942, 598942P, 598943, 598943P, 598944, 598944P, 598945, 598945P, 598946P, 598947, 598948, 598949, 598949P, 598950, 598951, 598952, 598953, 598955, 598966, 598978, , , , , , 5110201 511049 5110202 511036 511034 511032 511031 511016 511015 511014 511012 511011 5989207 5989206 5989202 5989201 598997 598996 598995 598994 598992 598991 598987 598986, 5110206, 5110207)