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Singapore HSA registration DE0509090

EpiSurf Episealer Talus

Singapore flagSingapore·CLASS C·Episurf Operations AB·Registered March 22, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0509090
Registration Date
March 22, 2024
Retention Due Date
March 21, 2026
Product description
The Episealer Talus (hereinafter also referred to as Episealer) is an individualised endoprosthetic resurfacing implant, intended to be used as cartilage and bone replacement for ankle talar dome osteochondral defects, covering a part of the joint. It is intended to give the patient improved ankle joint function and pain relief. The Episealer is a single-use product and must not be re-used. It is delivered sterile.
Product Owner
Name
Episurf Operations AB
Short Name
Episurf Operations AB
Address
Karlavagen 60, 114 49 Stockholm, SWEDEN
Registrant
Name
HUMEDICAL (S) PTE. LTD.
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Importer
Name
HUMEDICAL (S) PTE. LTD.
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #06-17, SINGAPORE 159471
Model information
Model Name(s)
Episealer Talus, Diameter = 15 mm Length = 13-22 mm Epidrill, Diameter = 14.8 (18.8 hat) mm Length = 82.7 mm Epidrill, Diameter = 14.8 (18.8 hat) mm Length = 82.7 mm Drilling Socket, Diameter = 25 mm Length = 37 mm Drilling Socket, Diameter = 25 mm Length = 37 mm Adjustment Socket, Diameter = 25 mm Length = 20 mm Adjustment Socket, Diameter = 25 mm Length = 20 mm Pin socket, Diameter = 18.4 mm Length = 42 mm Pin socket, Diameter = 18.4 mm Length = 42 mm Epidummy, Diameter = 14.7 mm Length = 91.3 mm Epidummy, Diameter = 14.7 mm Length = 91.3 mm Epimandrel, Diameter = 22 mm Length = 130-150 mm Epimandrel, Diameter = 22 mm Length = 130-140 mm
Model Identifier(s)
41115 42115 42115N 43115 43115N 43415 43415N 43815 43815N 44115 44115N 47115 47115N
About this record

Access comprehensive regulatory information for EpiSurf Episealer Talus in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509090 and owned by Episurf Operations AB. The device was registered on March 22, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C