160115
IV
Delisted
Procedure Kit/Trays, Lead Extraction, Pacemaker/Defibrillatorๆฏๅๅ /ๆ็๏ผๅฏผ็ฎกๅผๅฏผ็บฟๆๅ๏ผ่ตทๆๅจ/้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
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18111
State
N/A
Status
Delisted
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Manufacturer (่ฃฝ้ ๅ)
Spectranetics Corporation
Spectranetics Corporation
United States
็พๅฝ
9965 Federal Drive, Colorado Springs, Colorado 80921, USA
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Authorised Representative (AR)
Innotronik Hong Kong Ltd.
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ฌๅธ
28776787
Regulatory Timeline
Registration Date
March 08, 2021
Expiry Date
April 07, 2026
Delist Date
January 09, 2024
Remarks
Delisted.
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Product Models
GlideLight Laser Sheath (500-301, 500-302, 500-303)