140266
IV
current
Stent/Grafts, Vascular, Coronaryๆฏๆถ/็งปๆค็ฉ,่ก็ฎก,ๅ ็ถๅจ่
This profile provides complete Hong Kong MDACS registration information for Stent/Grafts, Vascular, Coronary. 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, Coronary
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20452
Product Code Detail
20452 Stent/Grafts, Vascular, Coronary
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Biotronik AG
Biotronik Ag
Switzerland
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Ackerstrasse 6, 8180 Bulach, Switzerland
Ackerstrasse 6, 8180 ๅธๆ่ตซ, ็ๅฃซ
Authorised Representative (AR)
Biotronik Hong Kong Limited
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ฌๅธ
31904500
Regulatory Timeline
Registration Date
April 18, 2024
Expiry Date
August 11, 2029
Product Models
PK Papyrus Covered Coronary Stent System (369380, 369381, 369382, 369383, 369384, 369385, 369386, 369387, 369388, 369389, 369390, 369391, 369392, 369393, 381789, 381790, 381791)
PK ็บธ่่็บธ่ฆ็ๅ ็ถๅจ่ๆฏๆถ็ณป็ป (369380, 369381, 369382, 369383, 369384, 369385, 369386, 369387, 369388, 369389, 369390, 369391, 369392, 369393, 381789, 381790, 381791)