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Singapore HSA registration DE0503028

Lento Medical Innovation PtoleMedic System

Singapore flagSingapore·CLASS B·Lento Medical Innovation, Inc.·Registered April 24, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0503028
Registration Date
April 24, 2019
Change Notification Approval Date
July 09, 2020
Retention Due Date
April 23, 2026
Product description
The PtoleMedic System is a software interface and image manipulation system used to transfer DICOM images from a Magnetic Resonance Imaging (MRI) system. The PtoleMedic System creates a surgical plan and produces a custom surgical instrument intended to assist the surgeon in the orientation and placement of Total Knee Replacement (TKR) components intra-operatively by guiding the marking of bone or tissue before cutting.
Product Owner
Name
Lento Medical Innovation, Inc.
Short Name
Lento Medical Innovation, Inc.
Address
15110 Northwest Freeway, Suite 150 Houston, TX 77040, UNITED STATES
Registrant
Name
ASIA ACTUAL PTE. LTD.
Address
116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Importer
Name
SPRINT MEDICAL PTE LTD
Address
16 AYER RAJAH CRESCENT, TEMPCO TECHNOMINIUM, #04-05B, SINGAPORE 139965
Model information
Model Name(s)
Lento Medical PtoleMedic System
Model Identifier(s)
Lento Medical PtoleMedic System
About this record

Access comprehensive regulatory information for Lento Medical Innovation PtoleMedic System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503028 and owned by Lento Medical Innovation, Inc.. The device was registered on April 24, 2019.

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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