DRAP REGISTERED MEDICAL DEVICE
Capiox NX19 Oxygenator with Integrated Arterial Filter and UltraPrime Technology is registered with DRAP under number MDIR-0005743 as a Class B (low to moderate risk) medical device, imported. The listed holder is Universal Enterprises. It is listed as valid until 23 Oct 2028.
Screening result
MDIR-0005743 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00079
| Device | Capiox NX19 Oxygenator with Integrated Arterial Filter and UltraPrime Technology |
|---|---|
| Class | B |
| Listed holder | Universal Enterprises |
| Holder address | 29, Block-3, Overseas Co-Operative Housing Society, Stadium Road, Karachi |
| Manufacturing site | M/s Terumo Cardiovascular System Corporation, 125 Blue Ball Road, Elkton, MD 21921, USA. |
| Issued | 24 Oct 2023 |
| Renewal date | 23 Oct 2028 |
| Licence | ELI-00079 |
Specifications
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Screened 5 Oct 2026, 13:29 (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-0002552 | Capiox Oxygenator [3CX*RX15RW30 3CX*RX15RE30 3CX*RX15RW40 3CX*RX15RE40] | Class D |
| MDIR-0003405 | Carbon Sterile Surgical Blades | Class B |
| MDIR-0004371 | Capoiox FX Extra-corporeal Membrane Oxygenator | Class D |
| MDIR-0005692 | Terumo Custom Tubing Pack | Class B |
| MDIR-0006940 | AQUABIRD Surgical Sealant. [MAB2G-01, MAB1G-01] | Class D |
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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.