Pure Global
190014
III
current

Lithotripters, Extracorporeal็ขŽ็ŸณๅŠจ็‰ฉ,ไฝ“ๅค–ๅŠจ็‰ฉ

This profile provides complete Hong Kong MDACS registration information for Lithotripters, Extracorporeal. 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: Lithotripters, Extracorporeal

็”ขๅ“่ณ‡่จŠ๏ผš ็ขŽ็ŸณๅŠจ็‰ฉ,ไฝ“ๅค–ๅŠจ็‰ฉ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
III
Product Code
16758
Product Code Detail
16758 Lithotripters, Extracorporeal
State
current
Status
N/A
Pure Global
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DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Dornier MedTech GmbH
Dornier Medtech Gmbh
Germany
ๅพทๅ›ฝ
Argelsrieder Feld 7, 82234 Wessling, Germany
Argelsrieder Feld 7, 82234 ้Ÿฆๆ–ฏๆž—, ๅพทๅ›ฝ
Authorised Representative (AR)
Tronda Electronics Limited
ๅˆ›่พพๅŒป็–—็”ตๅญๆœ‰้™ๅ…ฌๅธ
26482822
Regulatory Timeline
Registration Date
July 24, 2024
Expiry Date
January 10, 2029
Product Models
Dornier Delta III (DELTA III XRAY 7.5KW/SW E180 (K1038988), DELTA III XRAY 15KW/SW E180 (K1038989), DELTA III RC XRAY 7.5KW/SW E180 (K1038990), DELTA III RC XRAY 15KW E180 (K1038991), DELTA III XRAY 7.5KW/SW E180 FARSIGHT (K1038992), DELTA III XRAY 15KW/SW E180 FARSIGHT (K1038993), DELTA III RC XRAY 7.5KW/SW E180 FARSIGHT (K1038994), Dornier Relax+ (K1018869), DELTA III RC XRAY 15KW/SW E180 FARSIGHT (K1038995), Dornier Relax+ Endo (K1043571)), Dornier Delta Pro III (DELTA III PRO XRAY 7.5KW/SW E180 (K1045935), DELTA III PRO XRAY 15KW/SW E180 (K1045936), DELTA III PRO RCM XRAY 7.5KW/SW E180 (K1045940), DELTA III PRO RCM XRAY 15KW/SW E180 (K1045939))
ๅคšๅฐผๅฐ” Delta III (DELTA III XRAY 7.5KW/SW E180 (K1038988), DELTA III XRAY 15KW/SW E180 (K1038989), DELTA III RC XRAY 7.5KW/SW E180 (K1038990), DELTA III RC XRAY 15KW E180 (K1038991), DELTA III XRAY 7.5KW/SW E180 FARSIGHT (K1038992), DELTA III XRAY 15KW/SW E180 FARSIGHT (K1038993), DELTA III RC XRAY 7.5KW/SW E180 FARSIGHT (K1038994), Dornier Relax+ (K1018869), DELTA III RC XRAY 15KW/SW E180 FARSIGHT (K1038995), Dornier Relax+ Endo (K1043571)), Dornier Delta Pro III (DELTA III PRO XRAY 7.5KW/SW E180 (K1045935), DELTA III PRO XRAY 15KW/SW E180 (K1045936), DELTA III PRO RCM XRAY 7.5KW/SW E180 (K1045940), DELTA III PRO RCM XRAY 15KW/SW E180 (K1045939))