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Remel Haemophilus influenzae Agglutinating Sera - HSA Registration DE0016000

Access comprehensive regulatory information for Remel Haemophilus influenzae 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 DE0016000 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.

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CLASS B IVD
DE0016000
Remel Haemophilus influenzae Agglutinating Sera
HSA Registration Number: DE0016000
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Product Description

Haemophilus influenzae Agglutinating Sera are intended for use in the qualitative slide agglutination test and in counterimmunoelectrophoresis (CIE) to identify serologically the type antigen of pathogenic strains of H. influenzae (types a to f) for epidemiological and diagnostic purposes.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
HSA Product Code
HSAMDB00106
HS Code
38220090
Registration Information
Registration Number
DE0016000
Registration Date
July 17, 2014
Retention Due Date
July 16, 2025
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)
H influenzae type a Agglutinating Sera H influenzae type b Agglutinating Sera H influenzae type c Agglutinating Sera H influenzae type d Agglutinating Sera H influenzae type e Agglutinating Sera H influenzae type f Agglutinating Sera
Model Identifier(s)
R30166001 R30166101 R30166201 R30166301 R30166401 R30166501