HSA · registration DE0509425Zhejiang CuraWay Medical Technology Co.,Ltd Automatic Core Biopsy Instrument
SingaporeGeneral & Plastic SurgeryClass BZhejiang CuraWay Medical Technology Co., Ltd.
Official record identity
- Registration number
- DE0509425
- Model name
- Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument; Automatic Core Biopsy Instrument
- Model identifier
- ABN 1208; ABN 1210; ABN 1213; ABN 1216; ABN 1220; ABN 1225; ABN 1408; ABN 1410; ABN 1413; ABN 1416; ABN 1420; ABN 1425; ABN 1608; ABN 1610; ABN 1613; ABN 1616; ABN 1620; ABN 1625; ABN 1808; ABN 1810; ABN 1813; ABN 1816; ABN 1820; ABN 1825; ABN 2008; ABN 2010; ABN 2013; ABN 2016; ABN 2020; ABN 2025
- Registration date
- June 20, 2024
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Zhejiang CuraWay Medical Technology Co., Ltd.
- Registrant / registration holder
- MEDICAL IMAGING SYSTEMS PTE. LTD.
Official description
Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidney, breast, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Additional source fields
- Product owner address
- Room 106, Building 1, Room 293, Building 2, No. 600, 21st Avenue, Baiyang Sub-district, Qiantang New District, 310018 Hangzhou City, Zhejiang Province, China
- Registrant address
- 28 SIN MING LANE, #02-143, MIDVIEW CITY, Singapore 573972
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.