Pure Global
190133
IV
current

Leads, External Cardiac Pacemaker, Myocardialๅฏผ่”็บฟใ€ๅค–้ƒจๅฟƒ่„่ตทๆๅ™จใ€ๅฟƒ่‚Œ

This profile provides complete Hong Kong MDACS registration information for Leads, External Cardiac Pacemaker, Myocardial. 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, External Cardiac Pacemaker, Myocardial

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ่”็บฟใ€ๅค–้ƒจๅฟƒ่„่ตทๆๅ™จใ€ๅฟƒ่‚Œ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
16989
Product Code Detail
16989 Leads, External Cardiac Pacemaker, Myocardial
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Ethicon, LLC
Ethicon, Inc.
Puerto Rico;United States
ๆณขๅคš้ปŽๅ„;็พŽๅ›ฝ
Highway 183 Km 8.3, San Lorenzo, Puerto Rico, 00754, USA
้ซ˜้€Ÿๅ…ฌ่ทฏ 183 Km 8.3, ๅœฃๆด›ไผฆ็ดข, ๆณขๅคš้ปŽๅ„, 00754, ็พŽๅ›ฝ
Authorised Representative (AR)
Johnson & Johnson (Hong Kong) Limited
ๅผบ็”Ÿ (้ฆ™ๆธฏ) ๆœ‰้™ๅ…ฌๅธ
27386080
Regulatory Timeline
Registration Date
February 19, 2024
Expiry Date
April 24, 2029
Product Models
Temporary Cardiac Pacing Wire (TPW10, TPW20, TPW30, TPW32)
ไธดๆ—ถๅฟƒ่„่ตทๆ็บฟ(TPW10ใ€TPW20ใ€TPW30ใ€TPW32)