Helix PTCA Balloon Dilatation Catheter - DRAP MDIR-0005241 (Class D)

DRAP REGISTERED MEDICAL DEVICE

Helix PTCA Balloon Dilatation Catheter (PTCA Coronary Dilatation Balloon Catheter) is registered with DRAP under number MDIR-0005241 as a Class D (high risk) medical device, imported. The listed holder is Health Tec. It is listed as valid until 22 Jun 2028.

Screening result

i
Number type: imported, registered (Class B, C or D)
MDIR-0005241
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Found in DRAP's published list
DRAP registered Class B/C/D list, 28 Aug 2025
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Listed valid until 22 Jun 2028
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Holder has a DRAP import licence on file
ELI-00046
DeviceHelix PTCA Balloon Dilatation Catheter (PTCA Coronary Dilatation Balloon Catheter)
ClassD
Listed holderHealth Tec
Holder addressHouse No. 10-B, Street 24, Valley Road, Westridge 1, Rawalpindi
Manufacturing siteM/s cNovate Medical B.V. Hogebrinkerweg 31, 3871 KM Hoevelaken, The Netherlands
Issued23 Jun 2023
Renewal date22 Jun 2028
LicenceELI-00046

Specifications

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Screened 5 Oct 2026, 07:42 (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-0000054Xlimus Sirolimus Eluting Coronary Stent SystemClass D
MDIR-0000266Pointer Angiographic CatheterClass D
MDIR-0000267Accoat GuidewireClass D
MDIR-0000268Poseidon Hydrophilic Nitinol Guide WireClass D
MDIR-0000879SCW Hemostasis Valve SetsClass B
MDIR-0000880SCW Transradial Introducer SetsClass B
MDIR-0000881SCW Introducer SetsClass B
MDIR-0000882SCW Guide WireClass B
MDIR-0002654SCW (Balloon Inflation Device)Class B
MDIR-0004615EVEREST SC (PTCA Balloon Dilatation Catheter)Class D
MDIR-0004616FORCE NC (PTCA Balloon Dilatation Catheter Non-complaint)Class D
MDIR-0004617SUMMIT CTO (PTCA Balloon Dilatation Catheter)Class D

Similar devices from other companies

Same device type listed by other holders, useful when comparing suppliers.

MDIR-0004775Helix PTCA Balloon Dilatation Catheter (PTCA Coronary Dilatation Balloon Catheter)Class DA.H Distributors

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.