DRAP REGISTERED MEDICAL DEVICE
Transseptal Needle (Septal Puncture Needle) is registered with DRAP under number MDIR-0006679 as a Class D (high risk) medical device, imported. The listed holder is Intek Coporation (Pvt) Ltd.. It is listed as valid until 2 Apr 2029.
Screening result
MDIR-0006679 · 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 | Transseptal Needle (Septal Puncture Needle) |
|---|---|
| Class | D |
| Listed holder | Intek Coporation (Pvt) Ltd. |
| Holder address | Office No. 501, Kohistan Tower, Opp AFIC, The Mall, Rawalpindi. |
| Manufacturing site | M/s Synaptic Medical Corporation 1959 Kellogg Avenue, Carlsbad CA 92008 USA. M/s Synaptic Medical Limited Building C, 100Kechuang 6th Street, Bijing Economic-Technological Development Area, Beijing, P.R China |
| Issued | 3 Apr 2024 |
| Renewal date | 2 Apr 2029 |
Specifications
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Screened 6 Oct 2026, 22:30 (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-0005687 | Gusta PTCA Balloon Dilatation Catheter | Class D |
| MDIR-0006035 | Angioway Y-Hemostasis Valve set | Class B |
| MDIR-0006678 | NaviEase (Intracardiac Catheter Introducer Kit) | 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-0006762 | BRK-1 Transseptal Needle (Trans septal Needle) | Class D | Physiomed (Pvt) Ltd. |
| MDIR-0004133 | BROCKEN- BROUGH curved Needle (Cardiac transseptal needle). [EP003994SEP003997S] | Class D | Medtronic Pakistan (Pvt) Ltd. |
| MDIR-0002464 | Transseptal Needle [TSNC-18-71.0, TSNC-19-56.0] | Class D | Verizon |
| MDIR-0001838 | BRK Transseptal Needle | Class D | Physiomed (Pvt) Ltd |
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.