DRAP REGISTERED MEDICAL DEVICE
BONASTENT Bonashim Stent Biliary stent (Self-Expandable Metallic Stent) is registered with DRAP under number MDIR-0002274 as a Class C (moderate to high risk) medical device, imported. The listed holder is Raffay Associates. Its listed renewal date (9 Mar 2026) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0002274 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00021
| Device | BONASTENT Bonashim Stent Biliary stent (Self-Expandable Metallic Stent) |
|---|---|
| Class | C |
| Listed holder | Raffay Associates |
| Holder address | Office No 04, 2nd Floor, Ahmed Plaza Range Road, Rawalpindi, Godown : Same as above |
| Manufacturing site | M/s Sewoon Medical Co., Ltd 60 Dorim-gil,IPjang Myeon Seobuk-Gu, Cheonan-SI, Chungheongnam-DO, Korea |
| Issued | 10 Mar 2021 |
| Renewal date | 9 Mar 2026 |
| Licence | ELI-00021 |
Specifications
No supplier specifications yet.
Supplier of this device? Add specifications (free during launch)
Sign in or create a free account to add specifications.
Screened 6 Oct 2026, 16:47 (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-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 |
| MDIR-0007756 | Bonastent (Self-Expandable Metallic Duodenal/ Pyloric Un-Covered Stent) | Class C |
Corrections
Is something on this page wrong? Report a correction
Corrections are checked against the evidence before anything changes on this page.
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.