DRAP REGISTERED MEDICAL DEVICE
Helix PTCA Balloon Dilatation Catheter (PTCA Coronary Dilatation Balloon Catheter) is registered with DRAP under number MDIR-0004775 as a Class D (high risk) medical device, imported. The listed holder is A.H Distributors. It is listed as valid until 21 Feb 2028.
Screening result
MDIR-0004775 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00225
| Device | Helix PTCA Balloon Dilatation Catheter (PTCA Coronary Dilatation Balloon Catheter) |
|---|---|
| Class | D |
| Listed holder | A.H Distributors |
| Holder address | House No. CB-708, Lane No 5, 1st Floor, Peshawar Road Rawalpindi |
| Manufacturing site | M/s eNovate Medical B.V Hogebrinkerweg 31, 3871 KM Hoevelaken, The Netherlands |
| Issued | 22 Feb 2023 |
| Renewal date | 21 Feb 2028 |
| Licence | ELI-00225 |
Specifications
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Screened 6 Oct 2026, 17:06 (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-0000440 | MSM DES Sirolimus Eluting Stent System | Class D |
| MDIR-0000441 | MSM PTCA SC Balloon Catheter | Class D |
| MDIR-0000442 | MSM CIS Cobalt Chromium Bare Metal Coronary Stent System | Class D |
| MDIR-0000443 | URSA Angiographic Catheter | Class D |
| MDIR-0004776 | Vecchio PTCA Balloon Dilatation Catheter (Non-complaint) (PTCA Coronary Dilatation Balloon Catheter) | Class D |
| MDIR-0005916 | Solmax (Inflation Device) | Class B |
| MDIR-0005917 | Solmax (Introducer sheaths) | Class B |
| MDIR-0005918 | Solmax (Manifold) | Class B |
| MDIR-0005919 | Solmax (Radial Artery compression device) | Class B |
| MDIR-0005920 | Solmax (High Pressure Extension Line) | Class B |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0005241 | Helix PTCA Balloon Dilatation Catheter (PTCA Coronary Dilatation Balloon Catheter) | Class D | Health Tec |
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.