Pure Global
230378
II
current

External Shock Wave Therapy Systems, Electrohydraulic, Dermatologicไฝ“ๅค–ๅ†ฒๅ‡ปๆณขๆฒป็–—็ณป็ปŸ,็”ตๆถฒ,็šฎ่‚ค็ง‘

This profile provides complete Hong Kong MDACS registration information for External Shock Wave Therapy Systems, Electrohydraulic, Dermatologic. 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: External Shock Wave Therapy Systems, Electrohydraulic, Dermatologic

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
34344
Product Code Detail
34344 External Shock Wave Therapy Systems, Electrohydraulic, Dermatologic
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Sanuwave, Inc.
Sanuwave, Inc.
United States
็พŽๅ›ฝ
11495 Valley View Road, Eden Prairie, Minnesota, 55344, USA
11495 Valley View Road, Eden Prairie, Minnesota, 55344, ็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
October 19, 2023
Expiry Date
October 19, 2028
Product Models
dermaPACE (DEP0330), PACE Applicator D (DAP0332)
dermaPACE (DEP0330), PACE ๆถ‚ๆŠนๅ™จ D (DAP0332)