180073
II
current
Catheters, Vascular, Angioplasty, Balloon, Peripheral Arteryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅคๅจๅจ่
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
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅคๅจๅจ่
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
34317
Product Code Detail
34317 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
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
March 03, 2023
Expiry Date
April 16, 2028
Product Models
Passeo-14 Peripheral Dilatation Catheter (380271, 380272, 380273, 380274, 380275, 380276, 380277, 380278, 380279, 380280, 380281, 380282, 380283, 380284, 380285, 380286, 380287, 380288, 380290, 380291, 380292, 380293, 380294, 380296, 380297, 380298, 380299, 380300, 380302, 380303, 380304, 380308, 380309, 380310, 380313, 380314, 380315, 380316, 380317, 380318, 380319, 380320, 380321, 380322, 380323, 380324, 380325, 380326, 380327, 380328, 380329, 380330, 380332, 380333, 380334, 380335, 380336, 380338, 380339, 380340, 380341, 380342, 380344, 380345, 380346, 380350, 380351, 380352)
Passeo-14 ๅคๅจๆฉๅผ ๅฏผ็ฎก (380271, 380272, 380273, 380274, 380275, 380276, 380277, 380278, 380279, 380280, 380281, 380282, 380283, 380284, 380285, 380286, 380287, 380288, 380290, 380291, 380292, 380293, 380294, 380296, 380297 , 380298, 380299, 380300, 380302, 380303, 380304, 380308, 380309, 380310, 380313, 380314, 380315, 380316, 380317, 380318, 380319, 380320, 380321, 380322, 380323, 380324, 380325, 380326, 380327, 380328, 380329, 380330, 380332, 380333, 380334, 380335, 380336, 380338, 380339, 380340, 380341, 380342, 380344, 380345, 380346, 380350, 380351, 380352)