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Singapore HSA registration DE0509101

Microptic SCA® Evolution CASA Sperm Class Analyzer

Singapore flagSingapore·CLASS B·Microptic SL·Registered March 25, 2024
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 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.
Product Owner
Name
Microptic SL
Short Name
Microptic SL
Address
Av Josep Tarradellas 8, 1-6, 08029, Barcelona, SPAIN
Registrant
Name
LabIVF Asia Pte Ltd.
Address
1 BUKIT BATOK CRESCENT, WCEGA PLAZA, #03-13/14, SINGAPORE 658064
Importer
Name
LABIVF ASIA PTE LTD.
Address
1 BUKIT BATOK CRESCENT, WCEGA PLAZA, #03-13/14, SINGAPORE 658064
Model information
Model Name(s)
SCA® Pack Human Edition: 1. SCA® Motility and Concentration + 2. SCA® Morphology + 3. SCA® Manual Counter SCA® Scope
Model Identifier(s)
SCA-PACK-H-02 (version 6.6) SCA-SCOPE (version 6.6)
About this record

Access comprehensive regulatory information for Microptic SCA® 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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