DRAP REGISTERED MEDICAL DEVICE
Introducer Version Braided or Non-Braided Kits to Introduce and Exchange Catheters and Endocavitary Electrodes, with Hemostasis Valve is registered with DRAP under number MDIR-0000214 as a Class D (high risk) medical device, imported. The listed holder is 4S International. Its listed renewal date (29 Feb 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000214 · 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-00290
| Device | Introducer Version Braided or Non-Braided Kits to Introduce and Exchange Catheters and Endocavitary Electrodes, with Hemostasis Valve |
|---|---|
| Class | D |
| Listed holder | 4S International |
| Holder address | 205, 2nd Floor Al - Fiza Glass Tower, Rashid Minhas Road, Karachi., Godown Address: Same as above |
| Manufacturing site | M/s Balton SP Z.O.O Nowy Swiat 7/1400496 Warszawa, Poland |
| Issued | 1 Mar 2019 |
| Renewal date | 29 Feb 2024 |
| Licence | ELI-00290 |
Specifications
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Screened 6 Oct 2026, 07:04 (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-0000212 | Coronary Angioplasty Catheter Fryderyk | Class D |
| MDIR-0000213 | Sirolimus Eluting Cobalt Chromium Coronary Stents [ALEX] with Delivery System RX | Class D |
| MDIR-0000215 | Cobalt Chromium Coronary Stents [CoFlexus] with Delivery System Rapid Exchange | Class D |
| MDIR-0000409 | Infusion Pump, General Purpose (Volumetric) | Class C |
| MDIR-0000410 | Syringe Infusion Pump | Class C |
| MDIR-0000411 | Sterile Hemostasis Introducer | Class D |
| MDIR-0000412 | Conqueror TM PTCA Balloon Catheter | Class D |
| MDIR-0000413 | APT Medical Hydrophilic Guidewire | Class D |
| MDIR-0000414 | Expressman TM Guiding Extension Catheter | Class D |
| MDIR-0000415 | APT Medical Microcatheter | Class D |
| MDIR-0000416 | March TM Guiding Catheter | Class D |
| MDIR-0000417 | APT Medical Hydrophilic Angiographic Catheter | 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.