Pure Global
150094
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

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United States
็พŽๅ›ฝ
22100 Bothell Everett Highway, Bothell, Washington 98021-8431, USA
22100ๅšๅกžๅฐ”ๅŸƒๅผ—้›ท็‰น้ซ˜้€Ÿๅ…ฌ่ทฏ,ๅšๅกžๅฐ”,ๅŽ็››้กฟ98021-8431,็พŽๅ›ฝ
Authorised Representative (AR)
28731887 / 28215111/ 26199663
Regulatory Timeline
Registration Date
September 01, 2022
Expiry Date
April 30, 2025
Product Models
Affiniti 70 Diagnostic Ultrasound System (Includes Affiniti 70C, 70G and 70W), Affiniti 50 Diagnostic Ultrasound System (Includes Affiniti 50C, 50G and 50W), Ultrasound transducer (3D9-3v, BP10-5ec, C5-1, C6-2, C8-5, C9-2, C9-4v, C10-3v, C10-4ec, L12-3, L-12-4, L12-5 50/L12-5, eL18-4, eL18-4 EMT, L18-5, mC7-2, S4-2, S5-1, S7-3t, S8-3, S8-3t, S12-4, V6-2, V9-2, VL13-5, X5-1, X7-2t), Transducer, Non-imaging (D2cwc, D2tcd, D5cwc), Surgical ultrasound imaging transducer (L15-7io), Planer Field Generator (989605418833), Table Top Field Generator (989605420101), Planer Field Generator Stand (989605464231), PercuNav Patient Tracker (10001), PercuNav Ultrasound Tracker (20004), PercuNav Adaptive Needle Tracker (41001), PercuNav Endocavity Ultrasound Tracker (21001), PercuNav Coaxial Needle Tracker (989605427983, 989605427993, 989605428003, 989605428013, 989605428023, 989605428033, 989605428043, 989605428053, 989605428063), Footswitch (989605375262)
Affiniti 70 ่ถ…ๅฃฐ่ฏŠๆ–ญ็ณป็ปŸ(ๅŒ…ๆ‹ฌ Affiniti 70Cใ€70G ๅ’Œ 70W)ใ€Affiniti 50 ่ถ…ๅฃฐ่ฏŠๆ–ญ็ณป็ปŸ(ๅŒ…ๆ‹ฌ Affiniti 50Cใ€50G ๅ’Œ 50W)ใ€่ถ…ๅฃฐๆข่ƒฝๅ™จ (3D9-3Vใ€BP10-5ecใ€C5-1ใ€C6-2ใ€C8-5ใ€C9-2ใ€C9-4Vใ€C10-3Vใ€C10-4ECใ€L12-3, L-12-4, L12-5 50/L12-5, eL18-4, eL18-4 EMT, L18-5, mC7-2, S4-2, S5-1, S7-3t, S8-3, S8-3t, S12-4, V6-2, V9-2, VL13-5, X5-1, X7-2t), ๆข่ƒฝๅ™จ, ้žๆˆๅƒ (D2cwc, D2tcd, D5cwc), ๅค–็ง‘่ถ…ๅฃฐๆˆๅƒๆข่ƒฝๅ™จ (L15-7io), ๅˆจๅบŠๅœบๅ‘็”Ÿๅ™จ (989605418833), ๅฐๅผๅœบๅ‘็”Ÿๅ™จ (989605420101), ๅˆจๅบŠๅœบๅ‘็”Ÿๅ™จ ๆ”ฏๆžถ (989605464231), PercuNav ๆ‚ฃ่€…่ฟฝ่ธชๅ™จ (10001), PercuNav ่ถ…ๅฃฐ่ฟฝ่ธชๅ™จ (20004), PercuNav ่‡ช้€‚ๅบ”้’ˆ่ฟฝ่ธชๅ™จ (41001), PercuNav ่…”ๅ†…่ถ…ๅฃฐ่ฟฝ่ธชๅ™จ (21001), PercuNav ๅŒ่ฝด้’ˆ่ฟฝ่ธชๅ™จ (989605427983, 989605427993, 989605428003, 989605428013, 989605428023, 989605428033, 989605428043, 989605428053, 989605428063), ่„š่ธๅผ€ๅ…ณ (989605375262)