RESTORE DEB
Class D (high risk) · MDIR-0005167 · Health Tec
DRAP REGISTERED MEDICAL DEVICE
RESTORE DEB (Paclitaxel Releasing PTCA Balloon Catheter) is registered with DRAP under number MDIR-0005167 as a Class D (high risk) medical device, imported. The listed holder is Health Tec. It is listed as valid until 31 May 2028.
Screening result
MDIR-0005167 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00046
| Device | RESTORE DEB (Paclitaxel Releasing PTCA Balloon Catheter) |
|---|---|
| Class | D |
| Listed holder | Health Tec |
| Holder address | House No. 10-B, Street 24, Valley Road, Westridge 1, Rawalpindi |
| Manufacturing site | M/s Cardionovum GmbH Am BonnerBogen 2, 53227 Bonn, Germany M/s ARTHESYS 4 rue Rene Razel, 91400 Saclay, France (Manufacturer of basic stent system) M/s NATEC Medical Ltd Maeva Centre Building,Business Park Ebene,Reduir, Mauritius (Manufacturer of basic stent system) M/s DOT GmbH Charles-Darwin-Ring 1a, 18059 Rostock, Germany (Coating of balloon catheter, packaging of final product) M/s HA2 Medizintechnik GmbH Tschaikowskistrasse 2, 38820 Halberstadt, Germany (Sterilization) |
| Issued | 1 Jun 2023 |
| Renewal date | 31 May 2028 |
| Licence | ELI-00046 |
Specifications
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Screened 7 Oct 2026, 04:54 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
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| MDIR-0002654 | SCW (Balloon Inflation Device) | Class B |
| MDIR-0004615 | EVEREST SC (PTCA Balloon Dilatation Catheter) | Class D |
| MDIR-0004616 | FORCE NC (PTCA Balloon Dilatation Catheter Non-complaint) | Class D |
| MDIR-0004617 | SUMMIT CTO (PTCA Balloon Dilatation Catheter) | Class D |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIE-0000333 | Prolystica Cleaning Chemistry (RESTORE Descaler & Neutralizing detergent) [1C45T6WR] | Class A | Global Marketing Services |
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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.