DRAP REGISTERED MEDICAL DEVICE
Hydrophilic Coated Guidewire is registered with DRAP under number MDIR-0004802 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
MDIR-0004802 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00414
| Device | Hydrophilic Coated Guidewire |
|---|---|
| Class | D |
| Listed holder | Melamine Emporium |
| Holder address | 814, Star City Mall, Saddar, Karachi |
| Manufacturing site | M/s SWL Medizin GmbH Havelstr.16 64295 Darmstadt Germany |
| Issued | 23 Feb 2023 |
| Renewal date | 22 Feb 2028 |
| Licence | ELI-00414 |
Specifications
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Screened 5 Oct 2026, 21:57 (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-0003676 | Tianck balloon Inflation device Disposable Inflation device | Class B |
| MDIR-0003677 | Tianck Closure Pad Topical Hemostasis wound dressing pads | Class B |
| MDIR-0003678 | Tianck Guidewire PTFE Coated Guidewire | Class D |
| MDIR-0003679 | Tianck Disposable Manifold Disposable Manifold | Class B |
| MDIR-0003680 | Tianck Hemostasis Valve Set Disposable Hemostasis Valve Set | Class B |
| MDIR-0003681 | Tianck Sterile Introducer Set Introducer sheath | Class B |
| MDIR-0004801 | Introducer Sets (Vascular Introducer Sets) | Class D |
| MDIR-0004803 | PTCA Guidewire | Class D |
| MDIR-0004804 | Guiding Catheter | Class D |
| MDIR-0004805 | NC Coronary Dilatation Catheter | Class D |
| MDIR-0004806 | Angiographic Catheter | Class C |
| MDIR-0004807 | PTFE Coated Guidewire | Class D |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0007013 | Amecath Nephrostomy Catheter Urology catheters (J-type, hydrophilic coated) | Class B | Allmed Solutions |
| MDIR-0002847 | Shunmei Hydrophilic coated Guide Wire | Class D | Ham International |
| MDIR-0002873 | I.Q Hydrophilic Coated Introducer Sheath Kit and accessories | Class B | ACP Systems |
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.
