Pure Global

Japan Lyophilization Laboratory HISCL Anti-TP - HSA Registration DE0504935

Access comprehensive regulatory information for Japan Lyophilization Laboratory HISCL Anti-TP in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0504935 and owned by Japan Lyophilization Laboratory. The device was registered on September 17, 2020.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS C IVD
DE0504935
Japan Lyophilization Laboratory HISCL Anti-TP
HSA Registration Number: DE0504935
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Detection of anti-TP antibody (TPAb) in serum or plasma.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0504935
Registration Date
September 17, 2020
Change Notification Approval Date
October 21, 2024
Retention Due Date
September 16, 2025
Product Owner
Short Name
Japan Lyophilization Laboratory
Address
Kiyose Factory, 3-1-5 Matsuyama, Kiyose-shi, Tokyo, 204-0022, JAPAN
Registrant
Address
9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Importer
Address
9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Model Information
Model Name(s)
HISCL Anti-TP Assay Kit HISCL Anti-TP Calibrator HISCL Anti-TP Assay Kit
Model Identifier(s)
CE-079-700 CJ-914-963 CN-364-470