180510
III
current
Stent/Grafts, Vascular, Peripheralๆฏๆถ/็งปๆค็ฉ,่ก็ฎก,ๅคๅจ
This profile provides complete Hong Kong MDACS registration information for Stent/Grafts, Vascular, Peripheral. 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: Stent/Grafts, Vascular, Peripheral
็ขๅ่ณ่จ๏ผ ๆฏๆถ/็งปๆค็ฉ,่ก็ฎก,ๅคๅจ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
20455
Product Code Detail
20455 Stent/Grafts, Vascular, Peripheral
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Biotronik AG
Biotronik Ag
Switzerland
็ๅฃซ
Ackerstrasse 6, Bulach, Switzerland
Ackerstrasse 6, ๅธๆ่ตซ, ็ๅฃซ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
31904500
Regulatory Timeline
Registration Date
October 05, 2023
Expiry Date
December 06, 2028
Product Models
PULSAR-35 Peripheral Self-Expanding Nitinol Stent System (379878, 379879, 379880, 379881, 379883, 379884, 379885, 379886, 379888, 379889, 379890, 379891, 379898, 379899, 379900, 379901, 379903, 379904, 379905, 379906, 379908, 379909, 379910, 379911, 379917, 379918, 379919, 379920, 379921, 379922, 379923, 379924, 379925, 379926, 379927, 379928, 379929, 379930, 379931, 379937, 379938, 379939, 379940, 379941, 379942, 379943, 379944, 379945, 379946, 379947, 379948, 379949, 379950, 379951)
PULSAR-35 ๅคๅจ่ช่จ่้้่ฏบๆฏๆถ็ณป็ป (379878, 379879, 379880, 379881, 379883, 379884, 379885, 379886, 379888, 379889, 379890, 379891, 379898, 379899, 379900, 379901, 379903, 379904, 379905, 379906, 379908, 379909, 379910, 379911, 379917, 379918, 379919, 379920, 379921, 379922, 379923, 379924, 379925, 379926, 379927, 379928, 379929, 379930, 379931, 379937, 379938, 379939, 379940, 379941, 379942, 379943, 379944, 379945, 379946, 379947, 379948, 379949, 379950, 379951)