DRAP REGISTERED MEDICAL DEVICE
Niti-S Hot Spaxus Tm Stent Pancreatic Pseudocyst/ gallbladder Stent is registered with DRAP under number MDIR-0005401 as a Class C (moderate to high risk) medical device, imported. The listed holder is Raffay Associates. It is listed as valid until 7 Aug 2028.
Screening result
MDIR-0005401 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00021
| Device | Niti-S Hot Spaxus Tm Stent Pancreatic Pseudocyst/ gallbladder Stent |
|---|---|
| Class | C |
| Listed holder | Raffay Associates |
| Holder address | Office No 04, 2nd Floor, Ahmed Plaza Range Road, Rawalpindi |
| Manufacturing site | M/s Taewoong Medical Co., Ltd 14, Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-do, South Korea 10022 |
| Issued | 8 Aug 2023 |
| Renewal date | 7 Aug 2028 |
| 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 5 Oct 2026, 18:38 (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-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.