200557
IV
current
Stents, Vascular, Peripheral, Balloon-Expandable, Iliacๆฏๆถ,่ก็ฎกๆฏๆถ,ๅคๅจๆฏๆถ,็ๅๆฉๅผ ๆฏๆถ,้ซๆฏๆถ
This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Peripheral, Balloon-Expandable, Iliac. 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: Stents, Vascular, Peripheral, Balloon-Expandable, Iliac
็ขๅ่ณ่จ๏ผ ๆฏๆถ,่ก็ฎกๆฏๆถ,ๅคๅจๆฏๆถ,็ๅๆฉๅผ ๆฏๆถ,้ซๆฏๆถ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
33055
Product Code Detail
33055 Stents, Vascular, Peripheral, Balloon-Expandable, Iliac
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Biotronik AG
Biotronik Ag
Switzerland
็ๅฃซ
Ackerstrasse 6, 8180 Bulach, Switzerland
Ackerstrasse 6, 8180 ๅธๆ่ตซ, ็ๅฃซ
Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
31904500
Regulatory Timeline
Registration Date
May 14, 2021
Expiry Date
May 14, 2026
Product Models
Dynamic (350110, 350111, 350112, 350113, 350114, 350115, 350116, 350117, 350118, 350119, 350120, 350121, 350122, 350123, 350124, 350125, 350126, 350127, 350128, 350129, 350130, 350131, 350132, 350133, 350134, 350135, 350136, 350137, 350138, 350139, 350140, 350141, 350142, 350143, 350144, 350145, 350146, 350147)
ๅจๆ (350110, 350111, 350112, 350113, 350114, 350115, 350116, 350117, 350118, 350119, 350120, 350121, 350122, 350123, 350124, 350125, 350126, 350127, 350128, 350129, 350130, 350131, 350132, 350133, 350134, 350135, 350136, 350137, 350138, 350139, 350140, 350141, 350142, 350143, 350144, 350145, 350146, 350147)

