220401
Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
导管、血管、血管成形术、球囊、外周动脉
Biotronik AG·IV·Hong Kong MDACS·Registered December 01, 2022
Device overview
- Risk class
- IV
- Product code
- 34317
- State
- current
- Status
- N/A
- Product code detail
- 34317 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
Manufacturer (製造商)
- Name
- Biotronik AGBiotronik Ag
- Country
- Switzerland瑞士
- Address
- Biotronic AG, Ackerstrasse 6, 8180 Bülach, SwitzerlandBiotronic AG, Ackerstrasse 6, 8180 Bülach, 瑞士
Authorised representative (AR)
- Name
- Biotronik Hong Kong Limited百多力香港有限公司
- Phone
- 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 Xeo外周扩张导管 (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)
About this record
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
產品資訊： 导管、血管、血管成形术、球囊、外周动脉