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Singapore HSA registration DE0509121

ScheBo Biotech Pancreatic Elastase 1 ELISA Stool Test

Singapore flagSingapore·CLASS B IVD·ScheBo Biotech AG·Registered March 28, 2024
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0509121
Registration Date
March 28, 2024
Retention Due Date
March 27, 2026
Product description
The ScheBo Pancreatic Elastase 1 ELISA Stool Test is an in-vitro diagnostic immunochemistry enzyme ELISA test intended for the quantitative measurement of pancreatic elastase 1, in human stool, to aid in the diagnosis of exocrine pancreatic insufficiency by healthcare professionals. Test results are to be used in conjunction with information obtained from patients' clinical evaluation and other diagnostic procedures.
Product Owner
Name
ScheBo Biotech AG
Short Name
ScheBo Biotech AG
Address
Netanyastr. 3, 35394 Giessen, GERMANY
Registrant
Name
UNISON COLLABORATIVE PTE. LTD.
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Importer
Name
UNISON COLLABORATIVE PTE. LTD.
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model information
Model Name(s)
ScheBo Extraction Buffer ScheBo Pancreatic Elastase 1 ELISA Stool Test ScheBo Master Quick-Prep
Model Identifier(s)
2 7 28-quick
About this record

Access comprehensive regulatory information for ScheBo Biotech Pancreatic Elastase 1 ELISA Stool Test 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 DE0509121 and owned by ScheBo Biotech AG. The device was registered on March 28, 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