DRAP REGISTERED MEDICAL DEVICE
Ultra 8 Intra Aortic Balloon Catheters is registered with DRAP under number MDIR-0000706 as a Class D (high risk) medical device, imported. The listed holder is UDL Distribution (Pvt) Ltd.. Its listed renewal date (15 Sep 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000706 · 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-00073
| Device | Ultra 8 Intra Aortic Balloon Catheters |
|---|---|
| Class | D |
| Listed holder | UDL Distribution (Pvt) Ltd. |
| Holder address | I-D -13, Sector 30, Korangi Industrial Area, Karachi., Godown Address: S-8/A, Translyari Quarters, SITE Near Gul Bai, In Line of Meezan Bank, Head Office, Karachi |
| Manufacturing site | M/s Arrow International, Inc (subsidiary of Teleflex, Inc.), 2400 Bernville Road Reading, PA 19605 USA (Legal Manufacturer) M/s Arrow International Inc 16 Elizabeth Dr. Chelmsford, MA 01824, USA M/s Arrow International, Inc 312 Commerce Place Asheboro, NC 27203 USA |
| Issued | 16 Sep 2019 |
| Renewal date | 15 Sep 2024 |
| Licence | ELI-00073 |
Specifications
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Screened 5 Oct 2026, 22:15 (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-0000425 | Wedge Pressure Balloon Catheter | Class D |
| MDIR-0000426 | Arrow Berman Angiographic Balloon Catheters | Class D |
| MDIR-0000427 | Arrow Two Lumen You-Bend Hemodialysis Catheterization | Class D |
| MDIR-0000428 | Arrow Two Lumen Hemodialysis Catherization Set | Class D |
| MDIR-0000707 | Rediguard Intra Aortic Balloon Catheters | Class D |
| MDIR-0000708 | Cannon II Plus Catheterization Set | Class D |
| MDIR-0000797 | SuperCross Micro Catheter | Class D |
| MDIR-0000798 | GuideLiner V3 Catheter | Class D |
| MDIR-0000940 | TrapLiner Catheter | Class D |
| MDIR-0000941 | Turnpike Catheter | Class D |
| MDIR-0000942 | Twin-Pass Torque Dual Access Catheter | Class D |
| MDIR-0001594 | Arrow Spring-Wire Guide | Class D |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
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| MDIR-0007370 | OptiCross 6HD60MHz Coronary Imaging Catheter (Intravascular Ultrasound Imaging Catheter, Single- Use | Class D | Ferozsons Laboratories Limited |
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| MDIR-0005301 | Refinity ST Intravascular Ultrasound Imaging Catheter [89900] | Class B | Digital Imaging Systems |
| MDIR-0005121 | ACUNAV Ultrasound Catheters (Intracardiac Ultrasound Imaging Catheter) [10043342, 08255790, 10135936, 10135910] | Class D | Johnson & Johnson Pakistan (Pvt) Ltd |
| MDIR-0004608 | Eagle Eve Platinum Digital and Short Tip IVUS Catheter (Intravascular Ultrasound Imaging Catheter) [85900P-85900PST] | Class D | Digital Imaging Systems |
| MDIR-0002321 | ULTRAFLON (Intravenous Cannula with injection Port) | Class B | Medco Health Care 155, Block -3 C.P Barar Society, Alamgir Road Karachi |
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.
