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Microptic SCAยฎ Evolution CASA Sperm Class Analyzer - HSA Registration DE0509101

Access comprehensive regulatory information for Microptic SCAยฎ Evolution CASA Sperm Class Analyzer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509101 and owned by Microptic SL. The device was registered on March 25, 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.

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CLASS B
DE0509101
Microptic SCAยฎ Evolution CASA Sperm Class Analyzer
HSA Registration Number: DE0509101
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Product Description

For use in a clinical laboratory setting to automatically analyse concentration, motility, vitality, morphology, DNA fragmentation and acrosome integrity of human semen samples according to WHO criteria for adult male fertility status diagnostic purposes. Results produced by the system are to be interpreted by trained licensed medical practitioners.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0509101
Registration Date
March 25, 2024
Retention Due Date
March 24, 2026
Product Owner
Short Name
Microptic SL
Address
Av Josep Tarradellas 8, 1-6, 08029, Barcelona, SPAIN
Registrant
Address
1 BUKIT BATOK CRESCENT, WCEGA PLAZA, #03-13/14, SINGAPORE 658064
Importer
Address
1 BUKIT BATOK CRESCENT, WCEGA PLAZA, #03-13/14, SINGAPORE 658064
Model Information
Model Name(s)
SCAยฎ Pack Human Edition: 1. SCAยฎ Motility and Concentration + 2. SCAยฎ Morphology + 3. SCAยฎ Manual Counter SCAยฎ Scope
Model Identifier(s)
SCA-PACK-H-02 (version 6.6) SCA-SCOPE (version 6.6)