Pure Global

DePuy Actis DuoFix Hip Prosthesis - HSA Registration DE0505210

Access comprehensive regulatory information for DePuy Actis DuoFix Hip Prosthesis in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505210 and owned by DePuy Ireland UC. The device was registered on December 07, 2020.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0505210
DePuy Actis DuoFix Hip Prosthesis
HSA Registration Number: DE0505210
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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. The ACTIS DUOFIX Hip Prosthesis is indicated for cementless use only.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0505210
Registration Date
December 07, 2020
Change Notification Approval Date
January 08, 2025
Retention Due Date
December 06, 2025
Product Owner
Short Name
DePuy Ireland UC
Address
Loughbeg, Ringaskiddy, Co. Cork, Ireland, IRELAND
Registrant
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model Information
Model Name(s)
ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 0 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 1 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 2 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 3 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 4 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 5 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 6 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 7 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 8 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 9 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 10 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 11 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper STD Size 12 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 0 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 1 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 2 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 3 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 4 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 5 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 6 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 7 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 8 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 9 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 10 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 11 ACTIS DUOFIX HIP PROTHESIS Cementless Femoral Stem 12/14 Taper HIGH Size 12 ACTIS BROACH STARTER ACTIS BROACH SIZE 0 ACTIS BROACH SZ 1 ACTIS BROACH SZ 2 ACTIS BROACH SZ 3 ACTIS BROACH SZ 4 ACTIS BROACH SZ 5 ACTIS BROACH SZ 6 ACTIS BROACH SZ 7 ACTIS BROACH SZ 8 ACTIS BROACH SZ 9 ACTIS BROACH SZ 10 ACTIS BROACH SZ 11 ACTIS BROACH SZ 12 ACTIS STD NK SZ0/1 ACTIS HIGH NK SZ0/1 ACTIS STD NK SZ2/3 ACTIS HIGH NK SZ2/3 ACTIS STD NK SZ4/5 ACTIS HIGH NK SZ4/5 ACTIS STD NK SZ6/7 ACTIS HIGH NK SZ6/7 ACTIS STD NK SZ8/9 ACTIS HIGH NK SZ8/9 ACTIS STD NK SZ10/11/12 ACTIS HIGH NK SZ10/11/12 ACTIS REAMER SIZE 0/1 ACTIS REAMER SIZE 2/3 ACTIS REAMER SIZE 4/5 ACTIS REAMER SIZE 6/7 ACTIS REAMER SIZE 8/9 ACTIS REAMER SIZE 10/11 ACTIS REAMER SIZE 12 ARTICUL/EZE TRIAL BALL GROOVED 28MM DIA +1.5 ARTICUL/EZE TRIAL HEAD 28MM +5 ARTICUL/EZE TRIAL HEAD 28MM +8.5 ARTICUL/EZE TRIAL HEAD 28MM +12 ARTICUL/EZE TRIAL HEAD 28MM +15.5 ARTIC/EZE TR BALL GRVD 32+1 ARTIC/EZE TR BALL GRVD 32+5 ARTIC/EZE TR BALL GRVD 32+9 ARTIC/EZE TR BALL GRVD 32+13 ARTIC/EZE TR BALL GRVD 32+17 12/14 ARTICULEZE TRIAL 40MM -2 12/14 ARTICUL 40MM TRIAL +1.5 12/14 ARTICUL 40MM TRIAL +5 12/14 ARTICUL 40MM TRIAL +8.5 12/14 ARTICUL 40MM TRIAL +12 12/14 ARTICUL 40MM TRIAL +15.5 ARTICUL/EZE TRIAL HEAD 36MM -2 ARTICUL/EZE TRIAL HEAD 36MM +1.5 ARTICUL/EZE TRIAL HEAD 36MM +5 ARTICUL/EZE TRIAL HEAD 36MM+8.5 ARTICUL/EZE TRIAL HEAD 36MM +12 ARTICUL/EZE TRIAL HEAD 36MM +15.5
Model Identifier(s)
101011005 101011010 101011020 101011030 101011040 101011050 101011060 101011070 101011080 101011090 101011100 101011110 101011120 101012005 101012010 101012020 101012030 101012040 101012050 101012060 101012070 101012080 101012090 101012100 101012110 101012120 201001002 201001005 201001010 201001020 201001030 201001040 201001050 201001060 201001070 201001080 201001090 201001100 201001110 201001120 201002100 201002150 201002200 201002250 201002300 201002350 201002400 201002450 201002500 201002550 201002600 201002650 201101210 201101220 201101230 201101240 201101250 201101260 201101270 253081000 253082000 253083000 253084000 253085000 253091000 253092000 253093000 253094000 253095000 253104000 253105000 253106000 253107000 253108000 253109000 253150000 253151000 253152000 253153000 253154000 253155000