DRAP REGISTERED MEDICAL DEVICE
SINUS-Superflex-635 (Auto expansible stent system made by Nitinol) is registered with DRAP under number MDIR-0003735 as a Class C (moderate to high risk) medical device, imported. The listed holder is Medisurg Innovatives HealthCare (Private) Limited. It is listed as valid until 5 Sep 2027.
Screening result
MDIR-0003735 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00242
| Device | SINUS-Superflex-635 (Auto expansible stent system made by Nitinol) |
|---|---|
| Class | C |
| Listed holder | Medisurg Innovatives HealthCare (Private) Limited |
| Holder address | Suit No. 106, Business Avenue, Block 6, PECHS, Shahrah-e-Faisal, Karachi |
| Manufacturing site | M/s Optimed Medizinsche instrumente GmbH Ferdinand-Porsche-Strasse 11, 76275 Ettilingen, Germany |
| Issued | 6 Sep 2022 |
| Renewal date | 5 Sep 2027 |
| Licence | ELI-00242 |
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-0003711 | Sinus-Superflex-DS (Vascular stent) | Class D |
| MDIR-0003729 | NYLOTRACK-35 (Semi Compliant Balloon Catheter) | Class B |
| MDIR-0003730 | NYLOTRACK-18 (Semi Compliant Balloon Catheter) | Class B |
| MDIR-0003731 | MARS PTA Balloon Catheter. | Class B |
| MDIR-0003732 | Big Lumen Aspiration Catheter & Set. | Class B |
| MDIR-0003733 | LOGLYSIS Catheter Embolectomy / Thrombectomy suction catheter | Class B |
| MDIR-0003734 | SILARO Nephrostomy Balloon Catheter and Sets. | Class B |
| MDIR-0003736 | CO2-Angioset (Used for injection as a contrast Media) | Class B |
| MDIR-0003737 | EQUADUS Stone Basket Nitinol Stone Basket | Class B |
| MDIR-0003738 | UNIVERSAL Stone Basket SF1 - Universal Stone Basket Helical SF1 - Universal Stone Basket Parallel | Class B |
| MDIR-0003739 | SINUS-Obliquus Self-Expanding Venous Stent. | Class C |
| MDIR-0003740 | SINUS-SuperFlex-535 Self-expanding stent made from nickel titanium Alloy. | 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.