160037
IV
current
Dilators, Surgical, Cardiacๆฉๅผ ๅจ, ๆๆฏ, ๅฟ่
This profile provides complete Hong Kong MDACS registration information for Dilators, Surgical, Cardiac. 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: Dilators, Surgical, Cardiac
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
11255
Product Code Detail
11255 Dilators, Surgical, Cardiac
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Spectranetics Corporation
Spectranetics Corporation
United States
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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
April 09, 2021
Expiry Date
February 05, 2026
Product Models
TightRail Rotating Dilator Sheath (545-509, 545-511, 545-513), TightRail Mini Rotating Dilator Sheath (540-009, 540-011)
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