DRAP REGISTERED MEDICAL DEVICE
BioFreedom Ultra (Biolimus - Cobalt Chromium Coated Coronary Stent System) is registered with DRAP under number MDIR-0007603 as a Class D (high risk) medical device, imported. The listed holder is Promed International. It is listed as valid until 15 Dec 2029.
Screening result
MDIR-0007603 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00044
| Device | BioFreedom Ultra (Biolimus - Cobalt Chromium Coated Coronary Stent System) |
|---|---|
| Class | D |
| Listed holder | Promed International |
| Holder address | Office No. 310, 3rd Floor, ISE Towers, Islamabad. |
| Manufacturing site | M/s Biosensors Europe SA 29 Rue de Lausanne 1110 Morges Switzerland M/s Biosensors Interventional Technologies Pte Ltd., 36 Jalan Tukang Singapour 619266 |
| Issued | 16 Dec 2024 |
| Renewal date | 15 Dec 2029 |
| Licence | ELI-00044 |
Specifications
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Screened 6 Oct 2026, 06:06 (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-0002201 | RISE NC Non-Complaint PTCA Balloon Catheter | Class D |
| 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 |
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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.