Pure Global
240207
II
current

Biopsy Gunsๆดปๆฃ€ๆžช

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

็”ขๅ“่ณ‡่จŠ๏ผš ๆดปๆฃ€ๆžช

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
17848
Product Code Detail
17848 Biopsy Guns
State
current
Status
N/A
Brand
BIOPINCE AND BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
BIOPINCE ๅ’Œ BIOPINCE ULTRA ๅ…จ่Šฏๆดปๆฃ€ไปช
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Argon Medical Devices, Inc.
Argon Medical Devices Inc.
United States
็พŽๅ›ฝ
1445 Flat Creek Road, Athens, Texas, 75751, USA
1445 Flat Creek Road, ้›…ๅ…ธ, ๅพทๅ…‹่จๆ–ฏๅทž, 75751, ็พŽๅ›ฝ
Authorised Representative (AR)
ARGON MEDICAL DEVICES (HONG KONG) COMPANY LIMITED
็ˆฑ็…ๅŒป็–—ๅ™จๆขฐ(้ฆ™ๆธฏ)ๆœ‰้™ๅ…ฌๅธ
21539836
Regulatory Timeline
Registration Date
June 04, 2024
Expiry Date
June 03, 2029
Product Models
BIOPINCE FULL CORE BIOPSY INSTRUMENT (360-1080-01, 360-1580-01, 360-2080-01, 370-1080-01, 370-1580-01), BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (360-1080-02, 360-1580-02, 360-2080-02, 370-1080-02, 370-1580-02, 360-1080-03, 360-1580-03, 360-2080-03, 370-1080-03, 370-1580-03), CO-AXIAL INTRODUCER NEEDLES (MCXS1610BP, MCXS1615BP, MCXS1810BP, MCXS1815BP, MCXS1820BP, MCXS1610BPU, MCXS1615BPU, MCXS1810BPU, MCXS1815BPU, MCXS1820BPU)
BIOPINCEๅ…จ่Šฏๆดปๆฃ€ไปช(360-1080-01ใ€360-1580-01ใ€360-2080-01ใ€370-1080-01ใ€370-1580-01)ใ€BIOPINCE่ถ…ๅ…จ่Šฏๆดปๆฃ€ไปช(360-1080-02ใ€360-1580-02ใ€360-2080-02ใ€370-1080-02ใ€370-1080-02ใ€370-1080-02ใ€370-1080-02ใ€360-1080-02ใ€360-1080-02ใ€360-1080-02ใ€360-1080-02ใ€370-1080-02ใ€370-1080-02ใ€360-1080-02ใ€370-1080-02ใ€370-1080-02ใ€360-1080-02ใ€370-1080-02ใ€370-1080-02ใ€370-1080-02ใ€370-1080-02ใ€370-1080-02ใ€370-1080-02ใ€370-1080-02ใ€370-1080-02ใ€370-1080-02ใ€370-1080-02ใ€70-1580-02ใ€360-1080-03ใ€360-1580-03ใ€360-2080-03ใ€370-1080-03ใ€370-1580-03)ใ€ๅŒ่ฝดๅฏผๅผ•้’ˆ(MCXS1610BPใ€MCXS1615BPใ€MCXS1810BPใ€MCXS1815BPใ€MCXS1820BPใ€MCXS1610BPUใ€MCXS1615BPUใ€MCXS1810BPUใ€MCXS1815BPUใ€MCXS1820BPU)