DRAP REGISTERED MEDICAL DEVICE
OREIN Guiding Catheter. is registered with DRAP under number MDIR-0003028 as a Class D (high risk) medical device, imported. The listed holder is Sapphire International. It is listed as valid until 2 Dec 2026.
Screening result
i
Imported device, registered with DRAP as Class D (high risk)
MDIR-0003028 · the class is taken from DRAP's list for this number
MDIR-0003028 · 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 2 Dec 2026
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Holder has a DRAP import licence on file
ELI-00430
ELI-00430
| Device | OREIN Guiding Catheter. |
|---|---|
| Class | D |
| Listed holder | Sapphire International |
| Holder address | Room No 903, 9th Floor Uni Center, I.I. Chundrigar Road Karachi |
| Manufacturing site | M/s LEPU Medical Technology (BEIJING) Co., Ltd. 37 Chaoqian Road, Changping District, Beijing 102200, China |
| Issued | 3 Dec 2021 |
| Renewal date | 2 Dec 2026 |
| Licence | ELI-00430 |
Specifications
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Screened 5 Oct 2026, 19:43 (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-0003026 | MINI TADPOLE Coronary Dilatation Catheter | Class D |
| MDIR-0003027 | NC TADPOLE Coronary Dilatation Catheter. | Class D |
| MDIR-0003029 | ULTRASKIN Hydrophilic Guidewire. | Class D |
| MDIR-0003030 | BALANCUM PTCA Guide Wire. | Class D |
| MDIR-0003031 | Demax Interventional Device Set Angiographic Kit | Class D |
| MDIR-0003032 | Demax MAINFOLDS Stopcock | Class D |
| MDIR-0003033 | Demax Introducer Sheath Kit Hydrophilic Vascular Catheter Introduction set, non-implantable | Class D |
| MDIR-0003253 | TADPOLE Coronary Dilatation Catheter | Class D |
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.