Pure Global
200013
II
current

Scanning Systems, Ultrasonic่ถ…ๅฃฐๆณขๆ‰ซๆ็ณป็ปŸ

This profile provides complete Hong Kong MDACS registration information for Scanning Systems, Ultrasonic. 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: Scanning Systems, Ultrasonic

็”ขๅ“่ณ‡่จŠ๏ผš ่ถ…ๅฃฐๆณขๆ‰ซๆ็ณป็ปŸ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
14278
Product Code Detail
14278 Scanning Systems, Ultrasonic
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United States
็พŽๅ›ฝ
22100 Bothell Everett Highway, Bothell, Washington, 98021-8431, USA
22100 Bothell Everett Highway, Bothell, Washington, 98021-8431, USA
Authorised Representative (AR)
28731887 / 28215111/ 26199663
Regulatory Timeline
Registration Date
September 01, 2022
Expiry Date
February 03, 2025
Product Models
EPIQ Diagnostic Ultrasound System (includes EPIQ CVx and CVxi), Ultrasound transducer (C5-1, C8-5, C9-2, L12-3, L12-5 50, eL18-4, L18-5, S5-1, S7-3t, S8-3t, S8-3, S9-2, S12-4, X5-1, X6-1, X7-2t, X7-2, X8-2ti, XL14-3, X8-2t), Transducer, Non-imaging (D2cwc, D2tcd, D5cwc), Surgical ultrasound transducer (L15-7io), Footswitch (989605375262), Planar Field Generator (989605418833), Planar Field Generator Stand (989605464231), Table Top Field Generator (989605420101), PercuNav Patient Tracker\t (10001), PercuNav Ultrasound Tracker (20004), PercuNav Adaptive Needle Tracker\t (41001), PercuNav Endocavity Ultrasound Tracker (21001), PercuNav Coaxial Needle Tracker (989605427983, 989605427993, 989605428003, 989605428013, 989605428023, 989605428033, 989605428043, 989605428053, 989605428063)
EPIQ ่ถ…ๅฃฐ่ฏŠๆ–ญ็ณป็ปŸ(ๅŒ…ๆ‹ฌ EPIQ CVx ๅ’Œ CVxi)ใ€่ถ…ๅฃฐๆข่ƒฝๅ™จ(C5-1ใ€C8-5ใ€C9-2ใ€L12-3ใ€L12-5 50ใ€eL18-4ใ€L18-5ใ€S5-1ใ€S7-3tใ€S8-3tใ€S8-3ใ€S9-2ใ€S12-4ใ€X5-1ใ€X6-1ใ€X7-2tใ€X7-2ใ€X8-2tiใ€XL14-3ใ€X8-2t)ใ€ๆข่ƒฝๅ™จใ€้žๆˆๅƒ(D2cwcใ€D2tcdใ€D5cwc)ใ€ๆ‰‹ๆœฏ่ถ…ๅฃฐๆข่ƒฝๅ™จ(L15-7io)ใ€่„š่ธๅผ€ๅ…ณ(989605375262)ใ€ๅนณ้ขๅœบๅ‘็”Ÿๅ™จ(989605418833)ใ€ๅนณ้ขๅœบๅ‘็”Ÿๅ™จๆ”ฏๆžถ(989605464231)ใ€ๆกŒ้ขๅœบๅ‘็”Ÿๅ™จ(989605420101)ใ€ PercuNav ๆ‚ฃ่€…่ฟฝ่ธชๅ™จ\t (10001), PercuNav ่ถ…ๅฃฐ่ฟฝ่ธชๅ™จ (20004), PercuNav ่‡ช้€‚ๅบ”้’ˆๅคด่ฟฝ่ธชๅ™จ\t (41001), PercuNav ่…”ๅ†…่ถ…ๅฃฐ่ฟฝ่ธชๅ™จ (21001), PercuNav ๅŒ่ฝด้’ˆ่ฟฝ่ธชๅ™จ(989605427983ใ€989605427993ใ€989605428003ใ€989605428013ใ€989605428023ใ€989605428033ใ€989605428043ใ€989605428053ใ€989605428063)