Pure Global
120437
IV
Expired.

Leads, Pacemaker, Implantable, Endocardialๅฏผ็บฟใ€่ตทๆๅ™จใ€ๆคๅ…ฅๅผใ€ๅฟƒๅ†…่†œ

This profile provides complete Hong Kong MDACS registration information for Leads, Pacemaker, Implantable, Endocardial. 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: Leads, Implantable Cardiac Pacemaker, Endocardial

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
12900
Product Code Detail
12900 Leads, Implantable Cardiac Pacemaker, Endocardial
State
Expired.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
United States
็พŽๅ›ฝ
4100 Hamline Avenue North, St Paul, Minnesota 55112-5798, USA
4100ๅ“ˆๅง†ๆž—ๅคง้“ๅŒ—,ๅœฃไฟ็ฝ—,ๆ˜Žๅฐผ่‹่พพๅทž55112-5798,็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
May 03, 2018
Expiry Date
December 31, 2022
Product Models
Flextend 2 (4095, 4096, 4097), Terminal pin fixation tool (6616)
ๆ‰ฉๅฑ• 2 (4095, 4096, 4097), ็ซฏๅญๅผ•่„šๅ›บๅฎšๅทฅๅ…ท (6616)