160308
II
current
Positioning Aidsๅฎไฝ่พ ๅฉ่ฃ ็ฝฎ
This profile provides complete Hong Kong MDACS registration information for Positioning Aids. 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: Positioning Aids
็ขๅ่ณ่จ๏ผ ๅฎไฝ่พ ๅฉ่ฃ ็ฝฎ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
16223
Product Code Detail
16223 Positioning Aids
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
United States
็พๅฝ
125 Blue Ball Road, Elkton, Maryland, 21921, USA
125 Blue Ball Road, ๅๅฐๅ
้กฟ, ้ฉฌ้ๅ
ฐๅท, 21921, ็พๅฝ
Authorised Representative (AR)
Terumo China (Hong Kong) Limited
ๆณฐๅฐ่ไธญๅฝ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
28660811/ 25663393
Regulatory Timeline
Registration Date
July 22, 2021
Expiry Date
August 24, 2026
Product Models
Hercules 360 Universal Stabilizer Arm(T401160), Hercules 3 Universal Stabilizer Arm(T401161), Atlas 360 Positioner Attachment(T401261U), Titan 360 Stabilizer Attachment(T401231U), Atlas Positioner Attachment(T401261), Pyramid Heart Positioner(T401250), Titan Stabilizer Attachment(T401231), Titan Stabilizer Attachment Long Shaft(T401231LS), OPVAC Synergy II(T401230), OPVAC Synergy II LS (T401240), OPVAC Synergy Ultra (T410200), StableSoft II Stabilizer (T401244), StableSoft II LS (T401245), StableSoft Ultra Stabilizer (T410210), Assistant with StableSoft 3L (T401209S), Assistant with StableSoft 3S (T401210S), Assistant with StableSoft 2L (T401211S), Assistant with StableSoft 2S (T401212S), Suture Holder Inserts (T401270)
ๅคงๅ็ฅ360้็จ็จณๅฎ่(T401160), ๅคงๅ็ฅ3ไธ่ฝ็จณๅฎ่(T401161), ้ฟ็นๆๆฏ360ๅฎไฝๅจ้ไปถ(T401261U), ๆณฐๅฆ360็จณๅฎๅจ้ไปถ(T401231U), ้ฟ็นๆๆฏๅฎไฝๅจ้ไปถ(T401261), ้ๅญๅกๅฟ่ๅฎไฝๅจ(T401250), ๆณฐๅฆ็จณๅฎๅจ้ไปถ(T401231), ๆณฐๅฆ็จณๅฎๅจ้ไปถ้ฟ่ฝด(T401231LS), OPVAC ๅๅII(T401230), OPVAC Synergy II LS (T401240), OPVAC Synergy Ultra (T410200), StableSoft II ็จณๅฎๅจ (T401244), StableSoft II LS (T401245), StableSoft Ultra Stabilizer (T410210), Assistant with StableSoft 3L (T401209S), Assistant with StableSoft 3S (T401210S), Assistant with StableSoft 2L (T401211S), Assistant with StableSoft 2S (T401212S), ็ผๅๆฏๆถๆไปถ (T401270)