DRAP REGISTERED MEDICAL DEVICE
APT Medical Hydrophilic Guidewire is registered with DRAP under number MDIR-0000413 as a Class D (high risk) medical device, imported. The listed holder is 4S International. Its listed renewal date (28 May 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000413 · 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 | APT Medical Hydrophilic Guidewire |
|---|---|
| Class | D |
| Listed holder | 4S International |
| Holder address | 205, 2nd Floor Al - Fiza Glass Tower, Rashid Minhas Road, Karachi. |
| Manufacturing site | M/s APT Medical Inc No. 009, Xiangxiang Road, Xiangxiang Economic Development Zone, Xiangxiang City Hunan, 411400, PR China |
| Issued | 29 May 2019 |
| Renewal date | 28 May 2024 |
| Licence | ELI-00290 |
Specifications
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Screened 6 Oct 2026, 02:22 (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-0000214 | Introducer Version Braided or Non-Braided Kits to Introduce and Exchange Catheters and Endocavitary Electrodes, with Hemostasis… | 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-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 |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0009592 | BrosMed Congor Hydrophilic Guidewire | Class B | Advance Cardiology System |
| MDIR-0009149 | Cure Sure Hydrophilic Guidewire [Staright Tip] | Class B | Cure Connect Pakistan |
| MDIR-0007645 | Victory 14 Polymer Tip Guidewire with Hydrophilic Coating (Guidewire for intravascular Interventional procedures) | Class D | Ferozsons Laboratories Limited |
| MDIR-0006951 | Sensor Nitinol Wire with Hydrophilic Tip (Gastro0urological guidewire, single-use) | Class B | Ferozsons Laboratories Limited |
| MDIR-0004802 | Hydrophilic Coated Guidewire | Class D | Melamine Emporium |
| MDIR-0004299 | X-Pedion Hydrophilic Guidewire [103-0605-200 , 203-0602-200] | Class D | Medtronic Pakistan (Pvt) Ltd. |
| MDIR-0004138 | Avigo Hydrophilic Guidewire (Peripheral vascular Guidewire, manual) | Class D | Medtronic Pakistan (Pvt) Ltd. |
| MDIR-0004144 | Mirage Hydrophilic Guidewire (Peripheral Vascular Guidewire, manual) | Class D | Medtronic Pakistan (Pvt) Ltd. |
| MDIR-0003121 | Stingray Guidewire with hydrophilic coating | Class D | Ferozsons Laboratories Limited |
| MDIR-0003029 | ULTRASKIN Hydrophilic Guidewire. | Class D | Sapphire International |
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.