Singapore HSA registration DE0506094
Merit Medical Temno Biopsy System
Singapore·CLASS B·MERIT MEDICAL SYSTEMS INC·Registered August 20, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0506094
- Registration Date
- August 20, 2021
- Change Notification Approval Date
- April 30, 2024
- Retention Due Date
- August 19, 2025
Product description
Temno are intended for use in obtaining core biopsy samples from soft tissue such as breast, kidney, liver, lung, thyroid, and various soft tissue masses. Not intended for use in bone.
Product Owner
- Short Name
- MERIT MEDICAL SYSTEMS INC
- Address
- 1600 WEST MERIT PARKWAY, SOUTH JORDAN, UTAH 84095, UNITED STATES
Registrant
- Address
- 198 YISHUN AVENUE 7, SINGAPORE 768926
Importer
- Address
- 512 ANG MO KIO AVENUE 8, CHENG SAN CREST, #02-2526, SINGAPORE 560512 10 RAEBURN PARK, #01-33, SINGAPORE 088702 198 YISHUN AVENUE 7, SINGAPORE 768926
Model information
- Model Name(s)
- Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno Temno
- Model Identifier(s)
- CT1411 CT1415 CT1420 CT1611 CT1615 CT1620 CT1811 CT1815 CT1820 CT2011 CT2015 CT2020 CT2215 CT2220 T1411 T1415 T1420 T146 T149 T1611 T1615 T1620 T166 T169 T1811 T1815 T1820 T186 T189 T1915 T2011 T2015 T2020 T206 T209 T2215 T226 T229
About this record
Access comprehensive regulatory information for Merit Medical Temno Biopsy System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506094 and owned by MERIT MEDICAL SYSTEMS INC. The device was registered on August 20, 2021.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B