Pure Global
210071
II
current

Bone Tamps, Inflatable้ชจๅคฏๅฎž,ๅ……ๆฐ”ๅผ

This profile provides complete Hong Kong MDACS registration information for Bone Tamps, Inflatable. 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: Bone Tamps, Inflatable

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
22539
Product Code Detail
22539 Bone Tamps, Inflatable
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Globus Medical, Inc.
Globus Medical Inc
United States
็พŽๅ›ฝ
Valley Forge Business Center, 2560 General Armistead Avenue, Audubon, PA, 19403, United States of America
Valley Forge ๅ•†ๅŠกไธญๅฟƒ, 2560 General Armistead Avenue, Audubon, PA, 19403, ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
February 22, 2021
Expiry Date
February 22, 2026
Product Models
AFFIRM VCF System (658.006S, 658.015S, 658.037S, 658.070S, 658.071S, 658.073S, 658.080S, 658.081S, 658.083S, 658.111S, 658.114S, 658.116S, 658.161S, 658.211S, 658.216S, 658.297S, 658.301S, 658.302S, 658.303S, 658.351S, 658.352S, 658.353S, 658.361S, 658.362S, 658.363S, 658.410S, 658.411S, 658.413S, 658.481S, 658.501S, 658.502S, 658.503S, 658.504S, 658.505S, 658.506S, 658.507S, 658.508S, 658.509S, 658.510S, 658.511S, 658.512S, 658.513S, 658.514S, 658.515S, 658.516S, 658.517S, 658.518S, 658.519S, 658.520S, 658.521S, 658.522S, 658.523S, 658.524S, 658.525S, 658.526S, 658.527S, 658.539S, 658.540S, 658.582S, 658.583S, 658.585S, 658.601S, 658.720S, 658.721S, 658.723S, 658.901S, 658.902S, 658.903S, 658.906S, 658.912S, 658.914S, 658.915S, 658.917S, 658.918S, 658.919S, 658.926S, 658.927S, 658.928S, 658.929S, 658.930S, 658.931S, 658.932S, 658.933S, 658.934S, 658.935S, 658.936S, 658.937S, 658.938S, 658.939S, 658.940S, 658.961S, 658.962S, 658.963S, 658.969S, 658.001, 658.007, 658.009, 958.001, 958.002, 958.008, 658.909S, 658.920S, 658.921S, 658.922S, 658.923S, 658.924S, 658.925S)
่‚ฏๅฎšVCF็ณป็ปŸ(658.006S,658.015S,658.037S,658.070S,658.071S,658.073S,658.080S,658.083S,658.111S,658.114S,658.116S,658.161S,658.211S,658.216S,658.297S,658.301S,658.302S,658.303S,658.351S,658.351S,658.658.351S, 658.352S, 658.353S, 658.361S, 658.362S, 658.363S, 658.410S, 658.411S, 658.413S, 658.481S, 658.501S, 658.502S, 658.503S, 658.504S, 658.505S, 658.506S, 658.507S, 658.508S, 658.510S, 658.511S, 658.512S, 658.513S, 658.514S, 658.515S, 658.517S, 658.518S, 658.518S, 658.518S, 658.518S, 658.518S, 658.518S, 658.518S, 658.518S, 658.518S, 658.518S, 658.518S 658.520S, 658.521S, 658.522S, 658.523S, 658.524S, 658.525S, 658.526S, 658.527S, 658.539S, 658.540S, 658.582S, 658.583S, 658.585S, 658.601S, 658.720S, 658.721S, 658.723S, 658.901S, 658.902S, 658.903S, 658.658.601S, 658.903S, 658.658.601S, 658.723S, 658.901S, 658.902S, 658.903S, 658.601S, 658.723S, 658.901S, 658.902S, 658.903S, 658.658.601S, 658.723S, 658.901S, 658.902S, 658.903S, 658.601S, 658.723S, 658.901S, 658.902S, 658.903S, 658.658.601S, 658.723S, 658.901S, 658.902S, 658.903S, 658.658.601S, 658.720S, 658.721S, 658.901S, 658.902S, 658.903S, 658.903S, 658.658.601S, 658.723S, 658.901S, 658.902S, 658.903S906S, 658.912S, 658.914S, 658.915S, 658.917S, 658.918S, 658.919S, 658.926S, 658.927S, 658.928S, 658.929S, 658.930S, 658.931S, 658.933S, 658.934S, 658.935S, 658.936S, 658.937S, 658.939S, 658.939S, 658.940S, 658.961S, 658.962S, 658.963S, 658.969S, 658.969S, 658.009, 958.002, 958.008, 658.909S, 658.920S, 658.921S, 658.922S, 658.923S, 658.924S, 658.925S)