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Singapore HSA registration DE0509769

Bio Preventive DNlite-DKD uPTM-FetA ELISA Kit

Singapore flagSingapore·CLASS B IVD·Bio Preventive Medicine Corp.·Registered September 11, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0509769
Registration Date
September 11, 2024
Retention Due Date
September 10, 2025
Product description
The DNlite-DKD uPTM-FetA ELISA Kit is a colorimetric immunoassay to quantify unique Fetuin-A with specific post translational modification (hereafter referred as E103) in urine. This product is an IVD for prognosis use and should be performed at qualified clinical laboratories by certified medical professionals, such as Medical Technologists. The concentration of E103 should be corrected by urine creatinine before applying to the clinic. The DNlite-DKD uPTM-FetA ELISA Kit is to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of kidney function in type 2 diabetes patients with albuminuria.
Product Owner
Name
Bio Preventive Medicine Corp.
Short Name
Bio Preventive Medicine Corp.
Address
6F-1., 6F-2., 6F-3., 6F-5., 6F-6., No, 18 Taiyuan St., Zhubei City, Hsinchu County 30265, TAIWAN
Registrant
Name
EMERGO SINGAPORE CONSULTING PRIVATE LIMITED
Address
1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
Name
WEAVEGEN PTE LTD
Address
21 TAN QUEE LAN STREET, HERITAGE PLACE, #02-04, SINGAPORE 188108
Model information
Model Name(s)
DNlite-DKD uPTM-FetA ELISA Kit
Model Identifier(s)
8103107
About this record

Access comprehensive regulatory information for Bio Preventive DNlite-DKD uPTM-FetA ELISA Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509769 and owned by Bio Preventive Medicine Corp.. The device was registered on September 11, 2024.

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 IVD