241008
IV
current
Catheters, Vascular, Angioplasty, Balloon, Coronaryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, 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: Catheters, Vascular, Angioplasty, Balloon, Coronary
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
34313
Product Code Detail
34313 Catheters, Vascular, Angioplasty, Balloon, Coronary
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
IMDS Operations B.V.
IMDS Operations B.V.
Netherlands
่ทๅ
ฐ
Ceintuurbaan Noord 150, 9301 NZ Roden, The Netherlands
Ceintuurbaan Noord 150, 9301 NZ Roden, ่ทๅ
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Authorised Representative (AR)
Biotronik Hong Kong Limited
็พๅคๅ้ฆๆธฏๆ้ๅ
ฌๅธ
31904500
Regulatory Timeline
Registration Date
August 16, 2024
Expiry Date
August 15, 2029
Product Models
TrapIT Trapping Balloon Catheter (TRP10015, TRP9015)
TrapIT ่ฏฑๆ็ๅๅฏผ็ฎก(TRP10015ใTRP9015)