DRAP REGISTERED MEDICAL DEVICE
Bonastent (Self-Expandable Metallic Esophageal with Shim Anti reflux valve Covered Stent) is registered with DRAP under number MDIR-0007757 as a Class C (moderate to high risk) medical device, imported. The listed holder is Raffay Associates. It is listed as valid until 26 Jan 2030.
Screening result
MDIR-0007757 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00021
| Device | Bonastent (Self-Expandable Metallic Esophageal with Shim Anti reflux valve Covered Stent) |
|---|---|
| Class | C |
| Listed holder | Raffay Associates |
| Holder address | Office No 04, 2nd Floor, Ahmed Plaza Range Road, Rawalpindi |
| Manufacturing site | M/s Sewoon Medical Co., Ltd 60 Dorim-gil, Ipjang-myeon, Seobuk-gu, Cheonan-Si, Chungcheongnaamdo, Korea |
| Issued | 27 Jan 2025 |
| Renewal date | 26 Jan 2030 |
| Licence | ELI-00021 |
Specifications
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Screened 6 Oct 2026, 00:20 (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-0002274 | BONASTENT Bonashim Stent Biliary stent (Self-Expandable Metallic Stent) | Class C |
| MDIR-0003697 | Niti-S SPAXUS Stent (Pancreatic Pseudocyst/Gallbladd er Stent) | Class C |
| MDIR-0004479 | Star RF Electrode - Fixed (monopolar) (Sterile Single Use RF coagulation electrode) [15G, 17G, 18G, 19G] | Class C |
| MDIR-0004603 | ELRA electrode ( Sterile single use RF coagulation electrode) | Class C |
| MDIR-0004604 | EUSRA RF Electrode (Sterile single-use RF coagulation electrode) | Class C |
| MDIR-0005171 | Niti-S Biliary Covered Stent (Kaffes) | Class C |
| MDIR-0005226 | VIVA combo RF Generator (RF Generator) [VCS10] | Class C |
| MDIR-0005401 | Niti-S Hot Spaxus Tm Stent Pancreatic Pseudocyst/ gallbladder Stent | Class C |
| MDIR-0005765 | Bonastent (Esophageal Covered) | Class C |
| MDIR-0005963 | Bonastent (Self-Expandable Metallic Biliary Un-Covered Stent) | Class C |
| MDIR-0007548 | BONASTENT (Partially Covered) (Self-Expandable Metallic (Partially Covered) | Class C |
| MDIR-0007755 | Bonastent (Self-Expandable Metallic Duodenal/ Pyloric Covered Stent) | Class C |
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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.