DRAP REGISTERED MEDICAL DEVICE
Gentafix Bone Cement is registered with DRAP under number MDIR-0006307 as a Class D (high risk) medical device, imported. The listed holder is Treu-Dynamic International (Pvt) Ltd. It is listed as valid until 21 Feb 2029.
Screening result
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Imported device, registered with DRAP as Class D (high risk)
MDIR-0006307 · the class is taken from DRAP's list for this number
MDIR-0006307 · the class is taken from DRAP's list for this number
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Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
DRAP registered Class B/C/D list, 28 Aug 2025
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Listed valid until 21 Feb 2029
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Holder has a DRAP import licence on file
ELI-00175
ELI-00175
| Device | Gentafix Bone Cement |
|---|---|
| Class | D |
| Listed holder | Treu-Dynamic International (Pvt) Ltd |
| Holder address | C-206, 2nd Floor city Towers, Main Boulevard, Gulberg, Lahore |
| Manufacturing site | M/s TEKNIMED 8 rue du Corps Franc Pommies - 65500 Vic en Bigorre - France M/s TEKNIMED ZI de Montredon Rue d'Apollon - 31240 L'Union - France |
| Issued | 22 Feb 2024 |
| Renewal date | 21 Feb 2029 |
| Licence | ELI-00175 |
Specifications
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Screened 6 Oct 2026, 04:26 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
Other DRAP registrations and enlistments listed for the same company.
| MDIR-0001732 | Genutech Total Knee Replacement system | Class C |
| MDIR-0001733 | Total Hip Replacement System | Class C |
| MDIR-0003774 | Bone cement Cemfix-1 Cemfix-3 (Polymethyl Methacrylate (PMMA) [T040140, T040340] | Class C |
| MDIR-0005042 | CERAFORM Bone Substitute | Class C |
| MDIR-0005487 | Maxillofacial Osteosynthesis System [Titan Screws and plates for Maxillofacial Osteosynthesis System] | Class C |
| MDIR-0005488 | Yasargil Aneurysm Clip | Class D |
| MDIR-0006130 | JDEvolution Plus (Standard Abutment, Dental Implants) | Class C |
| MDIR-0006163 | SCULTRA II (Total Shoulder Prosthesis, STANDARD) | Class C |
| MDIR-0006306 | Euro Screw NG | Class D |
| MDIR-0009574 | Omnipore Reconstruction Surgery Implants. | Class C |
| MDIR-0009575 | Hydromed Surgical Dressing | Class D |
| MDIR-0009612 | Osteopore PCL Scaffold Bone Filler | Class D |
Corrections
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.
