150238
II
current
Hand Drills, Surgical, Middle Earๆ้ป, ๅค็ง, ไธญ่ณ
This profile provides complete Hong Kong MDACS registration information for Hand Drills, Surgical, Middle Ear. 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: Hand Drills, Surgical, Middle Ear
็ขๅ่ณ่จ๏ผ ๆ้ป, ๅค็ง, ไธญ่ณ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
11339
Product Code Detail
11339 Hand Drills, Surgical, Middle Ear
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Medtronic Xomed, Inc.
Medtronic Plc
United States
็พๅฝ
6743 Southpoint Drive North, Jacksonville FL 32216, USA
6743ๅ็น้ฉฑๅจๅจๅ,ๆฐๅ
้็ปดๅฐFL 32216,็พๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
August 05, 2020
Expiry Date
August 05, 2025
Product Models
Drill Indigo High Speed Otologic (1845000), Attachment Indigo Otol (1845010, 1845020), Skeeter Ultra-Lite Oto-Tool (3055601), Accelerator Foot Control (3055607), Disp Non-Vented IRR Spike (3118535), Irrigation Tubing Set (3318503), Tubing Set High Speed Drill Coolant (3318506), IRR Tubing IPC Visao Bur GRD RC (3318603), Cooling Set IPC Visao (3318606), IRRIG Sleeve Visao Drill (3334610), Bur Guard 80K Visao Drill W/O IRRIG (3334625), Bur Guard 80K Visao Drill With IRRIG (3334635), Drill 80K Visao Handpiece (3334800)
้ป้่้ซ้่ณ็ง (1845000), ้ไปถ้่่ณ (1845010, 1845020), ๆฏๅบ็น่ถ
่ฝปๅ่ณๅทฅๅ
ท (3055601), ๅ ้ๅจ่ๆงๅถ (3055607), ๆๆฐด้ๆๆฐๅ
้จๆถ็็ๅฐๅณฐ (3118535), ็ๆบๆฒน็ฎกๅฅไปถ (3318503), ๆฒน็ฎก็ป้ซ้้ปๆบๅทๅดๆถฒ (3318506), IRR ๆฒน็ฎก IPC ็ปด่จ็ดข (3318603), ๅทๅด่ฃ
็ฝฎ IPC ็ปด่จ็ดข (3318606), IRRIG ๅฅ็ญ็ปด่จ็ดข้ป (3334610), Bur Guard 80K ็ปด่จ็ดข้ปๅคด (3334625), Bur Guard 80K ็ปด่จ็ดข้ปๅคด,ๅธฆ IRRIG (3334635),้ป 80K ็ปด่จ็ดขๆๆบ (3334800)