Medical Device Division · registration 220401ActiveBiotronik AG
Hong KongCatheters, Vascular, Angioplasty, Balloon, Peripheral ArteryClass IVBiotronik AG
Official record identity
- MDACS listing number
- 220401
- Model name
- 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)
- Registration date
- April 02, 2026
- Expiry date
- December 01, 2027
- Source update date
- June 15, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
- Published category
- Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
Official value: IV
Published parties
- Registrant / registration holder
- Teleflex Medical Hong Kong Limited
- Manufacturer
- Biotronik AG
Official description
Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
Additional source fields
- AMD nomenclature code
- 34317
- Local responsible person phone
- 62916211
- Published manufacturer address
- Biotronic AG, Ackerstrasse 6, 8180 Bülach, Switzerland
- Revision number
- b
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.