HSA · registration DE0509090EpiSurf Episealer Talus
- Registration number
- DE0509090
- Model name
- 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
- 41115; 42115; 42115N; 43115; 43115N; 43415; 43415N; 43815; 43815N; 44115; 44115N; 47115; 47115N
- Registration date
- March 22, 2024
- Risk class
- Class C
- Product owner
- Episurf Operations AB
- Registrant / registration holder
- HUMEDICAL (S) PTE. LTD.
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 address
- Karlavagen 60, 114 49 Stockholm, Sweden
- Registrant address
- 3791 JALAN BUKIT MERAH, #06-17, E-CENTRE @ REDHILL, Singapore 159471
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.