DRAP registered medical device · imported

PTFE Coated Guidewire

Class D (high risk) · MDIR-0004807 · Melamine Emporium

✓ DRAP status Listed Valid until 22 Feb 2028
Screened against DRAP's published lists

DRAP REGISTERED MEDICAL DEVICE

PTFE Coated Guidewire is registered with DRAP under number MDIR-0004807 as a Class D (high risk) medical device, imported. The listed holder is Melamine Emporium. It is listed as valid until 22 Feb 2028.

Screening result

i
Imported device, registered with DRAP as Class D (high risk)
MDIR-0004807 · 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 22 Feb 2028
✓
Holder has a DRAP import licence on file
ELI-00414
DevicePTFE Coated Guidewire
ClassD
Listed holderMelamine Emporium
Holder address814, Star City Mall, Saddar, Karachi
Manufacturing siteM/s SWL Medizin GmbH Havelstr.16 64295 Darmstadt Germany
Issued23 Feb 2023
Renewal date22 Feb 2028
LicenceELI-00414

Specifications

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Screened 7 Oct 2026, 00:03 (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-0003676Tianck balloon Inflation device Disposable Inflation deviceClass B
MDIR-0003677Tianck Closure Pad Topical Hemostasis wound dressing padsClass B
MDIR-0003678Tianck Guidewire PTFE Coated GuidewireClass D
MDIR-0003679Tianck Disposable Manifold Disposable ManifoldClass B
MDIR-0003680Tianck Hemostasis Valve Set Disposable Hemostasis Valve SetClass B
MDIR-0003681Tianck Sterile Introducer Set Introducer sheathClass B
MDIR-0004801Introducer Sets (Vascular Introducer Sets)Class D
MDIR-0004802Hydrophilic Coated GuidewireClass D
MDIR-0004803PTCA GuidewireClass D
MDIR-0004804Guiding CatheterClass D
MDIR-0004805NC Coronary Dilatation CatheterClass D
MDIR-0004806Angiographic CatheterClass C

Similar devices from other companies

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

MDIR-0007036Cooper (Disposable Guidewires, PTFE coated)Class BImtiaz Brothers
MDIR-0005772PTFE Coated Guide WiresClass DMedisurg Innovatives HealthCare (Private) Limited
MDIR-0003922Black and white (Nitinol guidewires, PTFE coated)Class DMedisurg Innovatives HealthCare (Private) Limited
MDIR-0002001Angiomed PTFE COATED GUIDE WIREClass DSurgi World
MDIR-0002871I.Q Guidewire PTFE Coated (urology guidewire)Class BACP Systems
MDIR-0000904Shunmei PTFE Coated Guide WireClass DHam International

Corrections

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Screen another number

Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.