DRAP REGISTERED MEDICAL DEVICE
BioFreedom Drug Coated Coronary Stent System is registered with DRAP under number MDIR-0003917 as a Class D (high risk) medical device, imported. The listed holder is Promed International. It is listed as valid until 6 Nov 2027.
Screening result
i
Imported device, registered with DRAP as Class D (high risk)
MDIR-0003917 · the class is taken from DRAP's list for this number
MDIR-0003917 · the class is taken from DRAP's list for this number
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Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
DRAP registered Class B/C/D list, 28 Aug 2025
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Listed valid until 6 Nov 2027
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Holder has a DRAP import licence on file
ELI-00044
ELI-00044
| Device | BioFreedom Drug Coated Coronary Stent System |
|---|---|
| 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 | 7 Nov 2022 |
| Renewal date | 6 Nov 2027 |
| Licence | ELI-00044 |
Specifications
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Screened 6 Oct 2026, 01:00 (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-0003918 | Powerline (PTCA Catheter) | Class D |
| MDIR-0007603 | BioFreedom Ultra (Biolimus - Cobalt Chromium Coated Coronary Stent System) | 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.