Pure Global
90336
IV
Expired.

Sizersๆ–ฝ่ƒถๆœบ

This profile provides complete Hong Kong MDACS registration information for Sizers. 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: Sizers

็”ขๅ“่ณ‡่จŠ๏ผš ๆ–ฝ่ƒถๆœบ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
18086
Product Code Detail
18086 Sizers
State
Expired.
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Manufacturer (่ฃฝ้€ ๅ•†)
AGA Medical Corporation
Aga Medical Corporation
United States
็พŽๅ›ฝ
5050 Nathan Lane North, Plymouth, Minnesota, 55442, USA
5050 Nathan Lane North, ๆ™ฎๅˆฉ่Œ…ๆ–ฏ, ๆ˜Žๅฐผ่‹่พพๅทž, 55442, ็พŽๅ›ฝ
Authorised Representative (AR)
Abbott Medical (Hong Kong) Limited
็พŽๅ›ฝ้›…ๅŸนๅŒป็–—็”จๅ“(้ฆ™ๆธฏ)ๆœ‰้™ๅ…ฌๅธ
29967688
Regulatory Timeline
Registration Date
September 21, 2018
Expiry Date
September 02, 2019
Product Models
AMPLATZER Sizing Balloon II (9-SB-018, 9-SB-024, 9-SB-034)
ๅฎ‰ๆ™ฎๆ‹‰็ญ–ๆ–ฝ่ƒถ็ƒ II (9-SB-018, 9-SB-024, 9-SB-034)