DRAP REGISTERED MEDICAL DEVICE
Amplatzer Valvular Plug III (occlusion device) [9-APVL3-042, 9-APVL3-063, 9-APVL3-084, 9-APVL3-103, 9-APVL3-105, 9-APVL3-123, 9-APVL3-125, 9-APVL3-143, 9-APVL3-145] is registered with DRAP under number MDIR-0003389 as a Class D (high risk) medical device, imported. The listed holder is Digital Imaging Systems. It is listed as valid until 18 May 2027.
Screening result
MDIR-0003389 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00094
| Device | Amplatzer Valvular Plug III (occlusion device) [9-APVL3-042, 9-APVL3-063, 9-APVL3-084, 9-APVL3-103, 9-APVL3-105, 9-APVL3-123, 9-APVL3-125, 9-APVL3-143, 9-APVL3-145] |
|---|---|
| Class | D |
| Listed holder | Digital Imaging Systems |
| Holder address | 121- Habitat Apartments, Shadman II, Ghaus-ul-Azam Road, Lahore |
| Manufacturing site | M/s Abbott Medical 5050 Nathan Lane North, Plymouth, MN 55442, USA |
| Issued | 19 May 2022 |
| Renewal date | 18 May 2027 |
| Licence | ELI-00094 |
Specifications
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Screened 6 Oct 2026, 16:47 (Pakistan time). A screening aid, not an official DRAP verification.
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| 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.
