220401
IV
current
Catheters, Vascular, Angioplasty, Balloon, Peripheral Arteryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅคๅจๅจ่
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Peripheral 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, Angioplasty, Balloon, Peripheral Artery
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅคๅจๅจ่
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
34317
Product Code Detail
34317 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Biotronik AG
Biotronik Ag
Switzerland
็ๅฃซ
Biotronic AG, Ackerstrasse 6, 8180 Bรผlach, Switzerland
Biotronic AG, Ackerstrasse 6, 8180 Bรผlach, ็ๅฃซ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
31904500
Regulatory Timeline
Registration Date
December 01, 2022
Expiry Date
December 01, 2027
Product Models
Passeo-35 Xeo Peripheral Dilatation Catheter (428777, 428778, 428779, 428780, 428781, 428782, 428783, 428784, 428786, 428787, 428788, 428789, 428790, 428791, 428792, 428793, 428794, 428795, 428796, 428797, 428798, 428799, 428800, 428801, 428802, 428803, 428804, 428805, 428806, 428807, 428808, 428809, 428810, 428811, 428812, 428813, 428814, 428815, 428816, 428817, 428818, 428819, 428820, 428821, 428822, 428823, 428824, 428825, 428826, 428827, 428828, 428829, 428830, 428831, 428832, 428833, 428834, 428835, 428836, 428837, 428838, 428839, 428840, 428841, 428842, 428843, 428844, 428845, 428846, 428847, 428848, 428849, 428850, 428851, 428852, 428853, 428854, 428855, 428856, 428857, 428858, 428860, 428861, 428862, 428863, 428864, 428865, 428866, 428867, 428868, 428869, 428870, 428871, 428872, 428873, 428874, 428875, 428876, 428877, 428878, 428879, 428880, 428881, 428882, 428883, 428884, 428885, 428886, 428887, 428888, 428889, 428890, 428891, 428892, 428893, 428894, 428895, 428896, 428897, 428898, 428899, 428900, 428901, 428902, 428903, 428904, 428905, 428906, 428907, 428908, 428909, 428910, 428911, 428912, 428913, 428914, 428915, 428916, 428917, 428918, 428919, 428920, 428921, 428922, 428923, 428924, 428925, 428926, 428927, 428928, 428929, 428930, 428931, 428932, 428934, 428935, 428936, 428937, 428938, 428939, 428940, 428941, 428942, 428943, 428944, 428945, 428946, 428947, 428948, 428949, 428950, 428951, 428952, 428953, 428954, 428955, 428956, 428957, 428958, 428959, 428960, 428961, 428962, 428963, 428964, 428965, 428966, 428967, 428968, 428969, 428970, 428971, 428972, 428973, 428974, 428975, 428976, 428977, 428978, 428979, 428980, 428981, 428982, 428983, 428984, 428985, 428986, 428987, 428988, 428989, 428990, 428991, 428992, 428993, 428994, 428995, 428996, 428997, 428998)
Passeo-35 Xeoๅคๅจๆฉๅผ ๅฏผ็ฎก (428777, 428778, 428779, 428780, 428781, 428782, 428783, 428784, 428786, 428787, 428788, 428789, 428790, 428791, 428792, 428793, 428794, 428795, 428796, 428797, 428798, 428799, 428800, , 428800 428801, , 428802, 428803, 428804, 428805, 428806, 428807, 428808, 428809, 428810, 428811, 428812, 428813, 428814, 428815, 428816, 428817, 428818, 428819, 428820, 428821, 428822, 428823, 428824, 428825, 428826, 428827, 428828, 428829, 428830, 428831, 428832, 428833, 428834, 428835, 428836, 428837, 428838, 428839, 428840, 428841, 428842, 428843, 428844, 428845, 428846, 428847, 428848, 428849, 428850, 428851, 428852, 428853, 428854, 428855, 428856, 428857, 428858, 428860, 428861, 428862, 428863, 428864, 428865, 428866, 428867, 428868, 428869, 428870, 428871, 428872, 428873, 428874, 428875, 428876, 428877, 428878, 428879, 428880, 428881, 428882, 428883, 428884, 428885, 428886, 428887, 428888, 428889, 428890, 428891, 428892, 428893, 428894, 428895, 428896, 428897, 428898, 428899, 428900, 428901, 428902, 428903, 428904, 428905, 428906, 428907, 428908, 428909, 428910, 428911, 428912, 428913, 428914, 428915, 428916, 428917, 428918, 428919, 428920, 428921, 428922, 428923, 428924, 428925, 428926, 428927, 428928, 428929, 428930, 428931, 428932, 428934, 428935, 428936, 428937, 428938, 428939, 428940, 428941, 428942, 428943, 428944, 428945, 428946, 428947, 428948, 428949, 428950, 428951, 428952, 428953, 428954, 428955, 428956, 428957, 428958, 428959, 428960, 428961, 428962, 428963, 428964, 428965, 428966, 428967, 428968, 428969, 428970, 428971, 428972, 428973, 428974, 428975, 428976, 428977, 428978, 428979, 428980, 428981, 428982, 428983, 428984, 428985, 428986, 428987, 428988, 428989, 428990, 428991, 428992, 428993, 428994, 428995, 428996, 428997, 428998)