Omniwire Pressure Guidewire Transducer, pressure, Catheter tip [89185, 89185J] - DRAP MDIR-0005302 (Class B)

DRAP REGISTERED MEDICAL DEVICE

Omniwire Pressure Guidewire Transducer, pressure, Catheter tip [89185, 89185J] is registered with DRAP under number MDIR-0005302 as a Class B (low to moderate risk) medical device, imported. The listed holder is Digital Imaging Systems. It is listed as valid until 9 Jul 2028.

Screening result

i
Imported device, registered with DRAP as Class B (low to moderate risk)
MDIR-0005302 · the class is taken from DRAP's list for this number
✓
Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
✓
Listed valid until 9 Jul 2028
✓
Holder has a DRAP import licence on file
ELI-00094
DeviceOmniwire Pressure Guidewire Transducer, pressure, Catheter tip [89185, 89185J]
ClassB
Listed holderDigital Imaging Systems
Holder address121- Habitat Apartments, Shadman II, Ghaus-ul-Azam Road, Lahore
Manufacturing siteM/s Volcano Corporation 3721 Valley Centre Drive, Suite 500, San Diego, California USA 92130 M/s Philips de Costa Rica S.R.L, Coyol Free Zone & Business Park, Building B37Coyol, Alajuela Costa Rica.
Issued10 Jul 2023
Renewal date9 Jul 2028
LicenceELI-00094

Specifications

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Screened 6 Oct 2026, 00:19 (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.

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MDIR-0000013RX Herculink Elite Peripheral Stent SystemClass C
MDIR-0000014RX Acculink Carotid Stent SystemClass D
MDIR-0000015Omnilink Elite Peripheral Stent SystemClass C
MDIR-0000016Hi-Torque Whisper Guide Wire with Hydrophilic CoatingClass D
MDIR-0000017Hi-Torque Balance Middle Weight Guide WireClass 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.