Therapy Cool Flex Ablation Catheter - DRAP MDIR-0004485 (Class D)

DRAP REGISTERED MEDICAL DEVICE

Therapy Cool Flex Ablation Catheter (Electrophysiology and Ablation Catheter) is registered with DRAP under number MDIR-0004485 as a Class D (high risk) medical device, imported. The listed holder is Physiomed (Pvt) Ltd.. It is listed as valid until 2 Jan 2028.

Screening result

i
Imported device, registered with DRAP as Class D (high risk)
MDIR-0004485 · 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 2 Jan 2028
✓
Holder has a DRAP import licence on file
ELI-00199
DeviceTherapy Cool Flex Ablation Catheter (Electrophysiology and Ablation Catheter)
ClassD
Listed holderPhysiomed (Pvt) Ltd.
Holder address268/3, Kamal Road, Saddar,Rawalpindi.
Manufacturing siteM/s Irvine Biomedical Inc a St Jude Medical Company, 2375 Morse Ave, Irvine CA 92614, USA
Issued3 Jan 2023
Renewal date2 Jan 2028
LicenceELI-00199

Specifications

No supplier specifications yet.

Supplier of this device? Add specifications (free during launch)

Sign in or create a free account to add specifications.

Screened 6 Oct 2026, 18:36 (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-0000200Endurity Core CRT-Ps Implantabale Cardiac Pulse Generators (Pacemakers) [PM1152, PM2152]Class D
MDIR-0000201Endurity MRI (CRT-Ps) Implantabale Cardiac Pulse Generators (Pacemakers) [PM1172, PM2172]Class D
MDIR-0000202Fortify AssuraTM DR [CD2359-40Q, CD2359-40QC, MR Conditional]Class D
MDIR-0000203Ellipse TM VR [CD1377-36Q, CD1377-36QC]Class D
MDIR-0000204Quadra Allure MP RF CRT-P) [PM 3262]Class D
MDIR-0000205Tendril STS Implantable Cardiac Pacing Leads (Bradycardia and Left Heart Leads) [2088TC]Class D
MDIR-0000206Quadra Assura TM [CD3367-40, CD3367-40C]Class D
MDIR-0000207Durata TM [7121Q-58, 7120Q-65]Class D
MDIR-0000208Quartet TM [1456Q-75]Class D
MDIR-0000726CPS AimTM SL (Sittable Inner Catheter) with integrated valveClass D
MDIR-0000727Advisor FL Circular Mapping Catheter, Sensor Enabled (Circular Mapping Catheter)Class D
MDIR-0000728Livewire Streerable Electrophysiology CatheterClass D

Corrections

Is something on this page wrong? Report a correction

Corrections are checked against the evidence before anything changes on this page.

Screen another number

Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.