160114
IV
Expired.
Procedure Kit/Trays, Lead Extraction, Pacemaker/Defibrillatorๆๆฏๅฅไปถ/ๆ็ใๅฏผ็บฟๆๅใ่ตทๆๅจ/้ค้ขคๅจ
This profile provides complete Hong Kong MDACS registration information for Procedure Kit/Trays, Lead Extraction, Pacemaker/Defibrillator. 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: Procedure Kit/Trays, Lead Extraction, Pacemaker/Defibrillator
็ขๅ่ณ่จ๏ผ ๆๆฏๅฅไปถ/ๆ็ใๅฏผ็บฟๆๅใ่ตทๆๅจ/้ค้ขคๅจ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18111
Product Code Detail
18111 Procedure Kit/Trays, Lead Extraction, Pacemaker/Defibrillator
State
Expired.
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Spectranetics Corporation
Spectranetics Corporation
United States
็พๅฝ
9965 Federal Drive, Colorado Springs, Colorado 80921, USA
9965่้ฆ้ฉฑๅจๅจ,็ง็ฝๆๅคๆฏๆฎๆๆฏ,็ง็ฝๆๅคๅท80921,็พๅฝ
Authorised Representative (AR)
Innotronik Hong Kong Ltd.
ๆฐธๅๅ้ฆๆธฏๆ้ๅ
ฌๅธ
28776787
Regulatory Timeline
Registration Date
April 07, 2016
Expiry Date
April 07, 2021
Product Models
SLS II Laser Sheath (500-001, 500-012, 500-013)
SLS II ๆฟๅ
ๆคๅฅ (500-001, 500-012, 500-013)