Pure Global
190122
II
current

Power Systems, Electromechanical, Surgery, Orthopedic/Plastic็”ตๅŠ›็ณป็ปŸใ€ๆœบ็”ตใ€ๅค–็ง‘ใ€้ชจ็ง‘/ๅก‘ๆ–™

This profile provides complete Hong Kong MDACS registration information for Power Systems, Electromechanical, Surgery, Orthopedic/Plastic. 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: Power Systems, Electromechanical, Surgery, Orthopedic/Plastic

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
34910
Product Code Detail
34910 Power Systems, Electromechanical, Surgery, Orthopedic/Plastic
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
1941 Stryker Way, Portage MI 49002, USA
1941 ๅฒ่ต›ๅ…‹่ทฏ, ๆธฏๅฃ MI 49002, ็พŽๅ›ฝ
Authorised Representative (AR)
Stryker China Limited
็พŽๅ›ฝๅฒ่ต›ๅ…‹(ไธญๅ›ฝ)ๆœ‰้™ๅ…ฌๅธ
39691200
Regulatory Timeline
Registration Date
March 21, 2024
Expiry Date
April 24, 2029
Product Models
CORE 2 Console (5400-052-000 ), CORE HUMMER Disposable Irrigation Cassette (5290-075-000 ), CORE Disposable Irrigation Cassette (5400-050-001 ), CORE Dual Disposable Irrigation Cassette (5400-050-002 )
CORE 2 ๆŽงๅˆถๅฐ (5400-052-000 ), ๆ ธๅฟƒๆ‚้ฉฌไธ€ๆฌกๆ€ง็Œๆบ‰็›’ (5290-075-000 ), ๆ ธๅฟƒไธ€ๆฌกๆ€ง็Œๆบ‰็›’ (5400-050-001 ), ๆ ธๅฟƒๅŒไธ€ๆฌกๆ€ง็Œๆบ‰็›’ (5400-050-002 )