Medical Device Division · registration 190014ActiveDornier MedTech
Hong KongLithotripters, ExtracorporealClass IIIDornier MedTech GmbH
Official record identity
- MDACS listing number
- 190014
- Model name
- 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))
- Registration date
- July 24, 2024
- Expiry date
- January 10, 2029
- Source update date
- August 15, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Tronda Electronics Limited
- Manufacturer
- Dornier MedTech GmbH
Official description
Lithotripters, Extracorporeal
Additional source fields
- AMD nomenclature code
- 16758
- Traditional Chinese local responsible person
- 創達醫療電子有限公司
- Local responsible person phone
- 26482822
- Published manufacturer address
- Argelsrieder Feld 7, 82234 Wessling, Germany
- Revision number
- e
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.