DRAP REGISTERED MEDICAL DEVICE
Amplatzer TorqVue Exchange System [Cardiac Occulder delivery kit] is registered with DRAP under number MDIR-0000449 as a Class D (high risk) medical device, imported. The listed holder is Digital Imaging Systems. Its listed renewal date (20 Jun 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000449 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00094
| Device | Amplatzer TorqVue Exchange System [Cardiac Occulder delivery kit] |
|---|---|
| Class | D |
| Listed holder | Digital Imaging Systems |
| Holder address | 121- Habitat Apartments, Shadman II, Ghaus-ul-Azam Road, Lahore |
| Manufacturing site | M/s. AGA Medical Corporation 5050 Nathan Lane North, Plymouth, Minnesota, 55442, USA |
| Issued | 21 Jun 2019 |
| Renewal date | 20 Jun 2024 |
| Licence | ELI-00094 |
Specifications
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Screened 5 Oct 2026, 14:18 (Pakistan time). A screening aid, not an official DRAP verification.
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| MDIR-0000015 | Omnilink Elite Peripheral Stent System | Class C |
| MDIR-0000016 | Hi-Torque Whisper Guide Wire with Hydrophilic Coating | Class D |
| MDIR-0000017 | Hi-Torque Balance Middle Weight Guide Wire | 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.