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Regen Lab Regenkit-THT-3 - HSA Registration DE0018411

Access comprehensive regulatory information for Regen Lab Regenkit-THT-3 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018411 and owned by REGEN LAB SA. The device was registered on July 27, 2016.

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
DE0018411
Regen Lab Regenkit-THT-3
HSA Registration Number: DE0018411
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Product Description

Intended for the preparation of autologous platelet-rich plasma (A-PRP) and other plasma-derived products.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0018411
Registration Date
July 27, 2016
Change Notification Approval Date
October 04, 2023
Retention Due Date
July 26, 2025
Product Owner
Short Name
REGEN LAB SA
Address
En Budron B2 / CP 428, CH-1052 Le Mont Sur Lausanne, SWITZERLAND
Registrant
Address
111 NORTH BRIDGE ROAD, PENINSULA PLAZA, #21-01, SINGAPORE 179098
Importer
Address
18 SIN MING LANE, MIDVIEW CITY, #06-17, SINGAPORE 573960
Model Information
Model Name(s)
RegenKit®-THT-3
Model Identifier(s)
RK-THT-3