Singapore HSA registration DE0016001
Remel Shigella Polyvalent Agglutinating Sera
Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Microbiology
- HSA Product Code
- HSAMDB00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0016001
- Registration Date
- July 17, 2014
- Retention Due Date
- July 16, 2025
Product description
Shigella Polyvalent Agglutinating Sera are suitable for use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes. Antisera provide serological identification only; full identification of an organism must be made in conjunction with biochemical testing.
Product Owner
- Short Name
- Remel Europe Limited
- Address
- Remel House, Clipper Boulevaard West, Crossways, Dartford, Kent DA2 6PT, UNITED KINGDOM
Registrant
- Address
- 33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Importer
- Address
- 33 MARSILING IND ESTATE ROAD 3, #07-06, SINGAPORE 739256
Model information
- Model Name(s)
- Shigella dysenteriae Polyvalent Agglutinating Sera Shigella flexneri Polyvalent Agglutinating Sera Shigella boydii Polyvalent 1 Agglutinating Sera Shigella boydii Polyvalent 2 Agglutinating Sera Shigella boydii Polyvalent 3 Agglutinating Sera Shigella sonnei Phases 1& 2 Agglutinating Sera
- Model Identifier(s)
- R30163701 R30163801 R30163901 R30164001 R30164101 R30164201
About this record
Access comprehensive regulatory information for Remel Shigella Polyvalent Agglutinating Sera 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 DE0016001 and owned by Remel Europe Limited. The device was registered on July 17, 2014.
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