DRAP REGISTERED MEDICAL DEVICE
Gusta PTCA Balloon Dilatation Catheter is registered with DRAP under number MDIR-0005687 as a Class D (high risk) medical device, imported. The listed holder is Intek Coporation (Pvt) Ltd.. It is listed as valid until 7 Nov 2028.
Screening result
MDIR-0005687 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
That list covers manually issued licences only. Ask for a copy of the establishment licence.
| Device | Gusta PTCA Balloon Dilatation Catheter |
|---|---|
| Class | D |
| Listed holder | Intek Coporation (Pvt) Ltd. |
| Holder address | Office No. 501, Kohistan Tower, Opp AFIC, The Mall, Rawalpindi. |
| Manufacturing site | M/s Beijing Demax Medical Technology Co., Ltd., A13-7, Jingshengnansi Street, Tongzhou District, 101102 Beijing, People's Republic of China |
| Issued | 8 Nov 2023 |
| Renewal date | 7 Nov 2028 |
Specifications
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Screened 6 Oct 2026, 11:26 (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.
| MDIE-0000806 | Demax Radial Artery Compression Tourniquet | Class A |
| MDIR-0005614 | VenusP-Valve System [Transcatheter Pulmonary Valve with Delivery System] | Class D |
| MDIR-0006035 | Angioway Y-Hemostasis Valve set | Class B |
| MDIR-0006678 | NaviEase (Intracardiac Catheter Introducer Kit) | Class D |
| MDIR-0006679 | Transseptal Needle (Septal Puncture Needle) | Class D |
| MDIR-0006680 | Progreat Lambda (Peripheral vascular microcatheter) | Class D |
| MDIR-0007752 | AndraBalloon (PTA Balloon Catheter) | Class |
| MDIR-0007753 | Andra2Balloon (PTA Balloon Catheter) | Class |
| MDIR-0007754 | AndraStent Aortic (AndraStent Aortic) | Class D |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0006314 | Gusta (PTCA NC Balloon Dilatation Catheter) | Class D | Intek Corporation |
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.