Pure Global
160252
II
current

Guide Wiresๅฏผไธ

This profile provides complete Hong Kong MDACS registration information for Guide Wires. 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: Guide Wires

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผไธ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
11925
Product Code Detail
11925 Guide Wires
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Terumo Corporation
ๆณฐๅฐ”่Œ‚ๅŒป็–—ไบงๅ“๏ผˆๆญๅทž๏ผ‰ๆœ‰้™ๅ…ฌๅธ
Japan
ๆ—ฅๆœฌ
44-1, 2-chome, Hatagaya, Shibuya-Ku, Tokyo 151-0072, Japan
้‚ฎ็ผ–:151-0072, ไธœไบฌ้ƒฝๆถฉ่ฐทๅŒบๅนก่ฐท2ไธ็›ฎ44-1
Authorised Representative (AR)
Terumo China (Hong Kong) Limited
ๆณฐๅฐ”่Œ‚ไธญๅ›ฝ(้ฆ™ๆธฏ)ๆœ‰้™ๅ…ฌๅธ
28660811/ 25663393
Regulatory Timeline
Registration Date
October 07, 2024
Expiry Date
July 15, 2026
Product Models
Radifocus Glidewire Advantage (RA*CA35185CM, RA*CA35265CM, RA*CS35185CM, RA*CS35265CM, RA*FA18181CM, RA*FA18301CM, RA*FS18301CM, RA*FA14181CM, RA*FA14301CM, RA*FS14301CM)
Radifocus Glidewire Advantage(RA*CA35185CMใ€RA*CA35265CMใ€RA*CS35185CMใ€RA*CS35265CMใ€RA*FA18181CMใ€RA*FA18301CMใ€RA*FS18301CMใ€RA*FA14181CMใ€RA*FA14301CMใ€RA*FS14301CM)