Pure Global
80187
IV
Expired.

Occluders, Cardiac, Septum้—ญๅกžๅ™จใ€ๅฟƒ่„ใ€้š”่†œ

This profile provides complete Hong Kong MDACS registration information for Occluders, Cardiac, Septum. 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: Occluders, Cardiac, Septum

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
20414
Product Code Detail
20414 Occluders, Cardiac, Septum
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
October 19, 2018
Expiry Date
November 26, 2023
Product Models
AMPLATZER Duct Occluder (9-PDA-003, 9-PDA-004, 9-PDA-005, 9-PDA-006, 9-PDA-007, 9-PDA-008, 9-PDA-009 ), AMPLATZER Duct Occluder II (9-PDA2-03-04, 9-PDA2-04-04, 9-PDA2-05-04, 9-PDA2-06-04, 9-PDA2-03-06, 9-PDA2-04-06, 9-PDA2-05-06, 9-PDA2-06-06)
AMPLATZER ็ฎก้“้—ญๅกžๅ™จ (9-PDA-003, 9-PDA-004, 9-PDA-005, 9-PDA-006, 9-PDA-007, 9-PDA-008, 9-PDA-009), AMPLATZER ๅฏผ็ฎก้—ญ้”ๅ™จ II (9-PDA2-03-04, 9-PDA2-04-04, 9-PDA2-05-04, 9-PDA2-06-04, 9-PDA2-03-06, 9-PDA2-04-06, 9-PDA2-05-06, 9-PDA2-06-06)