DRAP REGISTERED MEDICAL DEVICE
Passeo-35 (Passeo-35 Peripheral Dilatation Catheter) is registered with DRAP under number MDIR-0000892 as a Class B (low to moderate risk) medical device, imported. The listed holder is Medisurg Innovatives Health Care. Its listed renewal date (28 Oct 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000892 · 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-00242
| Device | Passeo-35 (Passeo-35 Peripheral Dilatation Catheter) |
|---|---|
| Class | B |
| Listed holder | Medisurg Innovatives Health Care |
| Holder address | 1/6-N, Block-6,PECHS, Shahrah-e-Faisal Karachi., Godown Address: F-1102 Saima Square 1 Block 10-A, Gulshan-e-Iqbal, Karachi. |
| Manufacturing site | Biotronik AG, Ackerstrasse 6, 8180 BulachCH. Switzerland |
| Issued | 29 Oct 2019 |
| Renewal date | 28 Oct 2024 |
| Licence | ELI-00242 |
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, 21:56 (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-0000884 | Dynamic Renal (Dynamic Renal-Renal Stent System) | Class C |
| MDIR-0000885 | Passeo-14 (Passeo-14 Peripheral Dilatation Catheter) | Class B |
| MDIR-0000886 | Pantera Leo (Pantera Leo Fast-Exchange PTCA Catheter) | Class D |
| MDIR-0000887 | Pro-Kinetic Energy (Coronary Stent System) | Class D |
| MDIR-0000888 | Pulsar-35 (Pulsar-35 Peripheral Self Expanding Nitinol Stent System) | Class D |
| MDIR-0000889 | Passeo-18 Lux (Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter) | Class D |
| MDIR-0000890 | Pulsar -18 (Pulsar-18 Peripheral Self Expanding Nitinol Stent System) | Class D |
| MDIR-0000891 | Passeo-18 (Passeo-18 Peripheral Dilatation Catheter) | Class B |
| MDIR-0000893 | Pantera Pro (Pantera Pro Coronary Dilatation Catheter) | Class D |
| MDIR-0000894 | Dynamic (Dynamic Peripheral Stent and Delivery System) | Class D |
| MDIR-0002420 | ALN Optional Vena Cava Filter | Class D |
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.