Pure Global
240185
IV
current

Biopsy Site Markers, Breastๆดปๆฃ€้ƒจไฝๆ ‡ๅฟ—็‰ฉ,ไนณๆˆฟ

This profile provides complete Hong Kong MDACS registration information for Biopsy Site Markers, Breast. 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 Site Markers, Breast

็”ขๅ“่ณ‡่จŠ๏ผš ๆดปๆฃ€้ƒจไฝๆ ‡ๅฟ—็‰ฉ,ไนณๆˆฟ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
39659
Product Code Detail
39659 Biopsy Site Markers, Breast
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Devicor Medical Products, Inc.
Devicor Medical Products,Inc.
United States
็พŽๅ›ฝ
Fifth Floor, 300 E-Business Way, Cincinnati OH 45241, USA
Fifth Floor, 300 E-Business Way, ่พ›่พ›้‚ฃๆ OH 45241, USA
Authorised Representative (AR)
Medical Distributor Alliance Limited
่ฟˆ่ฟชไบšๆœ‰้™ๅ…ฌๅธ
35905130
Regulatory Timeline
Registration Date
May 21, 2024
Expiry Date
May 20, 2029
Product Models
HydroMARK Breast Biopsy Site Markers (4010-01-08-T1, 4010-01-08-T3, 4010-01-08-T4, 4010-01-08-S1, 4010-04-09-T1, 4010-04-09-T3, 4010-04-09-T4, 4010-04-09-S3, 4010-01-11-T1, 4010-01-11-T3, 4010-01-11-T4, 4010-02-15-S1, 4010-02-15-S3, 4010-02-15-T1, 4010-02-15-T3, 4010-02-15-T4, 4010-03-15-T1-SHORT, 4010-03-15-T3-SHORT, 4010-02-18-T3)
HydroMARKไนณ่…บๆดปๆฃ€้ƒจไฝๆ ‡ๅฟ—็‰ฉ(4010-01-08-T1ใ€4010-01-08-T3ใ€4010-01-08-T4ใ€4010-01-08-S1ใ€4010-04-09-T1ใ€4010-04-09-T3ใ€4010-04-09-T4ใ€4010-04-09-S3ใ€4010-01-11-T1ใ€40100 -01-11-T3, 4010-01-11-T4, 4010-02-15-S1, 4010-02-15-S3, 4010-02-15-T1, 4010-02-15-T3, 4010-02-15-T4, 4010-03-15-T1-SHORT, 4010-03-15-T3-SHORT, 4010-02-18-T3)