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Singapore HSA registration DE0508304

DePuy Ireland UC Marathon XLPE Cemented Cup

Singapore flagSingapore·CLASS C·DePuy Ireland UC·Registered July 18, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0508304
Registration Date
July 18, 2023
Change Notification Approval Date
June 06, 2024
Retention Due Date
July 17, 2025
Product description
Total hip arthroplasty is intended to replace the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or arthritic joint (typically due to non-inflammatory degenerative joint disease) 2. Failed previous hip surgery 3. Acute fracture of the femoral head or neck.
Product Owner
Name
DePuy Ireland UC
Short Name
DePuy Ireland UC
Address
Loughbeg, Ringaskiddy, Co. Cork, Ireland, IRELAND
Registrant
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
JOHNSON & JOHNSON PTE LTD Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
Marathon XLPE Cemented Cup 38mm TRIAL CUP Marathon XLPE Cemented Cup 45mm TRIAL CUP Marathon XLPE Cemented Cup 50mm TRIAL CUP Marathon XLPE Cemented Cup 53mm TRIAL CUP DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup DePuy Marathon XLPE Cemented Cup
Model Identifier(s)
962638001 962645000 962650000 962653000 965512238 965512240 965512243 965512245 965512247 965512250 965512253 965512840 965512843 965512845 965512847 965512850 965512853 965513245 965513247 965513250 965513253 965513650 965513653
About this record

Access comprehensive regulatory information for DePuy Ireland UC Marathon XLPE Cemented Cup in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508304 and owned by DePuy Ireland UC. The device was registered on July 18, 2023.

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