DRAP REGISTERED MEDICAL DEVICE
RISE NC Non-Complaint PTCA Balloon Catheter is registered with DRAP under number MDIR-0002201 as a Class D (high risk) medical device, imported. The listed holder is Promed International. Its listed renewal date (15 Feb 2026) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0002201 · 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-00044
| Device | RISE NC Non-Complaint PTCA Balloon Catheter |
|---|---|
| Class | D |
| Listed holder | Promed International |
| Holder address | Office No. 310, 3rd Floor, ISE Towers, Islamabad., Godown: CB-6349, Amarpak Plaza, Jhelum Road,Rawalpindi. |
| Manufacturing site | M/s Biosensors Europe SA 29 rue de Lausanne, 1110 Morges, Switzerland M/s Biosensors Interventional Technologies Pte Ltd., 36 Jalan Tukang, 619266, Singapore |
| Issued | 16 Feb 2021 |
| Renewal date | 15 Feb 2026 |
| Licence | ELI-00044 |
Specifications
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Screened 6 Oct 2026, 07:25 (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-0003909 | BIOMATRIX NEOFLEX (Drug [Biolimus-A09] Eluting Coronary Stent System) [QP-00014-001 QP-00013-001 D00019] | Class D |
| MDIR-0003910 | BIOMATRIX ALPHA (Drug [Biolimus-A09] Eluting Coronary Stent System). | Class D |
| MDIR-0003917 | BioFreedom Drug Coated Coronary Stent System | Class D |
| MDIR-0003918 | Powerline (PTCA Catheter) | Class D |
| MDIR-0007603 | BioFreedom Ultra (Biolimus - Cobalt Chromium Coated Coronary Stent System) | Class D |
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.