BIOMATRIX NEOFLEX - DRAP MDIR-0003909 (Class D)

DRAP REGISTERED MEDICAL DEVICE

BIOMATRIX NEOFLEX (Drug [Biolimus-A09] Eluting Coronary Stent System) [QP-00014-001 QP-00013-001 D00019] is registered with DRAP under number MDIR-0003909 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-0003909 · the class is taken from DRAP's list for this number
✓
Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
✓
Listed valid until 6 Nov 2027
✓
Holder has a DRAP import licence on file
ELI-00044
DeviceBIOMATRIX NEOFLEX (Drug [Biolimus-A09] Eluting Coronary Stent System) [QP-00014-001 QP-00013-001 D00019]
ClassD
Listed holderPromed International
Holder addressOffice No. 310, 3rd Floor, ISE Towers, Islamabad., Godown: CB-6349, Amarpak Plaza, Jhelum Road,Rawalpindi.
Manufacturing siteM/s Biosensors Europe SA, 29 Rue de Lausanne 1110 Morges-Switzerland. M/s Biosensors Interventional Technologies Pte Ltd., 36-Jalan Tukang Singapore, 619266.
Issued7 Nov 2022
Renewal date6 Nov 2027
LicenceELI-00044

Specifications

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Screened 6 Oct 2026, 21:25 (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-0002201RISE NC Non-Complaint PTCA Balloon CatheterClass D
MDIR-0003910BIOMATRIX ALPHA (Drug [Biolimus-A09] Eluting Coronary Stent System).Class D
MDIR-0003917BioFreedom Drug Coated Coronary Stent SystemClass D
MDIR-0003918Powerline (PTCA Catheter)Class D
MDIR-0007603BioFreedom 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.