DRAP REGISTERED MEDICAL DEVICE
TIN PTCA Balloon ( High Performance PTCA Balloon Catheter) is registered with DRAP under number MDIR-0001538 as a Class D (high risk) medical device, imported. The listed holder is A & E Medical. Its listed renewal date (9 Jun 2025) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0001538 · 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-00023
| Device | TIN PTCA Balloon ( High Performance PTCA Balloon Catheter) |
|---|---|
| Class | D |
| Listed holder | A & E Medical |
| Holder address | 323-Ata Turk Block, New Gardan Town, Lahore |
| Manufacturing site | M/s. SIS Medical AG Hungerbuelstrasse 12a, 8500 Frauenfeld, CH Switzerland |
| Issued | 10 Jun 2020 |
| Renewal date | 9 Jun 2025 |
| Licence | ELI-00023 |
Specifications
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Screened 5 Oct 2026, 21:12 (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-0000769 | Heartsync Multifunction Electrodes (single use defibrillator pads) | Class A |
| MDIR-0000785 | NIC 1.1 hydro (PTCA Balloon Catheter) | Class D |
| MDIR-0000786 | NIC Nano Hydro (PTCA Balloon Catheter) | Class D |
| MDIR-0000787 | BEO NC (PTCA Non Compliant Balloon Catheter) | Class D |
| MDIR-0000788 | SPIKE LC S (Bipolar) (Electrocatheters for temporary endocardial pacing and electrophysiological studies) | Class D |
| MDIR-0000794 | Angiographic Guide Wire | Class D |
| MDIR-0000943 | Accu-Sheath Introducer System Percutaneous Catheter | Class B |
| MDIR-0001537 | OPN NC PTCA Balloon (Super High Pressure PTCA Balloon) | Class D |
| MDIR-0001539 | NAMIC Angiographic Manifold | Class B |
| MDIR-0001540 | NAMIC Angiographic Control Syringe (Syringe, Angiographic) | Class B |
| MDIR-0001541 | Navilyst Angiographic Guide Wires (Catheter Guide Wire) | Class D |
| MDIR-0002324 | Inflation Device [Inflation Device 40 ATM REF# 96346 Inflation Device 55ATM REF# 96463] | Class B |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0007542 | LEETY PTCA Balloon Catheter (PTCA Balloon Catheter) | Class D | The Cure |
| MDIR-0007544 | Ultra LEETY HP PTCA Balloon Catheter) (PTCA Balloon Catheter) | Class D | The Cure |
| MDIR-0007633 | Selethru SC PTCA Balloon Dilatation Catheter | Class D | Pak Punjab Cardex Medical System |
| MDIR-0007634 | Selethru NC PTCA Balloon Dilatation Catheter | Class D | Pak Punjab Cardex Medical System |
| MDIR-0007041 | Firefighter NC PTCA BALLOON CATHETER | Class D | Microport Scientific Pakistan (Private) Limited |
| MDIR-0007042 | Firefighter PTCA BALLOON CATHETER | Class D | Microport Scientific Pakistan (Private) Limited |
| MDIR-0006534 | NC Quantum Apex Monorail PTCA Dilatation Catheter [Catheter, Angioplasty, Balloon Dilatation, basic] | Class D | Ferozsons Laboratories Limited |
| MDIR-0006314 | Gusta (PTCA NC Balloon Dilatation Catheter) | Class D | Intek Corporation |
| MDIR-0006148 | Euca VI [PTCA balloon Catheter] | Class D | Otsuka Pakistan Limited |
| MDIR-0005687 | Gusta PTCA Balloon Dilatation Catheter | Class D | Intek Coporation (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.