DRAP REGISTERED MEDICAL DEVICE
Simulus Flexible Annuloplasty Band is registered with DRAP under number MDIR-0004666 as a Class D (high risk) medical device, imported. The listed holder is Medtronic Pakistan (Pvt) Ltd.. It is listed as valid until 13 Feb 2028.
Screening result
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Imported device, registered with DRAP as Class D (high risk)
MDIR-0004666 · the class is taken from DRAP's list for this number
MDIR-0004666 · 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 13 Feb 2028
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Holder has a DRAP import licence on file
ELI-00273
ELI-00273
| Device | Simulus Flexible Annuloplasty Band |
|---|---|
| Class | D |
| Listed holder | Medtronic Pakistan (Pvt) Ltd. |
| Holder address | Ocean Tower, 21st Floor, Plot No.G-3, Khayaban-e-Iqbal, Block 09, Clifton, Karachi., Plot No. S1, Survey 231, Sector 2, Road No. 4000, Korangi Industrial Area, Karachi. |
| Manufacturing site | M/s MEDTRONIC INC 710 Medtronic Pkwy Minneapolis MN USA 55432 M/s Medtronic Heart Valves Division 1851 East Deere Ave. Santa Ana CA USA 92705 M/s Medtronic Mexico S.de R.L de CV Av. Paseo Cucupah 10510 El Lago Tijuana Baja California MEXICO C.P 22210 M/s Medtronic Inc 3800 ANNAPOLIS LANE, Minneapolis, MN, USA 55447 |
| Issued | 14 Feb 2023 |
| Renewal date | 13 Feb 2028 |
| Licence | ELI-00273 |
Specifications
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Screened 5 Oct 2026, 13:53 (Pakistan time). A screening aid, not an official DRAP verification.
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Other DRAP registrations and enlistments listed for the same company.
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| MDIE-0000322 | Medtronic Open Pivot Heart Valve Sizer Set [576, 577, 578] | Class A |
| MDIE-0000323 | Profile 3D Sizer Set (7680S) | Class A |
| MDIE-0000324 | Contour 3D Sizer Set (7690S) | Class A |
| MDIE-0000325 | CG Future sizer set (7638S) | Class A |
| MDIE-0000326 | Medtronic Annuloplasty Handle (7615) | Class A |
| MDIE-0000338 | Medtronic Annuloplasty Handle (752) [752, 752XL] | Class A |
| MDIE-0000339 | Simulus Flexible Ring/Band Accessory Kit, Model 750 | Class A |
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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.