Medical device registration holder
Health Tec
36 DRAP registrations and enlistments (16 Class B, 20 Class D) · Screen a DRAP number · Device types · Companies
DRAP lists
All devices of Health Tec
| DRAP no. | Device | Class | Status |
|---|---|---|---|
| MDIR-0000267 | Accoat Guidewire | D | Renewal passed |
| MDIR-0006833 | Champion PTCA Guide Wire (PTCA Guide Wire, CTO) | D | Valid to Apr 2029 |
| MDIR-0007793 | Champion PTCA Guide Wire (PTCA Guide wire) [CAR Type] | D | Valid to Mar 2030 |
| MDIR-0004821 | Erasmus NC PTA Dilatation Balloon Catheter | D | Valid to Feb 2028 |
| MDIR-0004615 | EVEREST SC (PTCA Balloon Dilatation Catheter) | D | Valid to Feb 2028 |
| MDIR-0004616 | FORCE NC (PTCA Balloon Dilatation Catheter Non-complaint) | D | Valid to Feb 2028 |
| MDIR-0005241 | Helix PTCA Balloon Dilatation Catheter (PTCA Coronary Dilatation Balloon Catheter) | D | Valid to Jun 2028 |
| MDIR-0004819 | Millau PTA Dilatation Balloon Catheter | D | Valid to Feb 2028 |
| MDIR-0000266 | Pointer Angiographic Catheter | D | Renewal passed |
| MDIR-0000268 | Poseidon Hydrophilic Nitinol Guide Wire | D | Renewal passed |
| MDIR-0004774 | Primum (Hydrophilic Guiding Catheter) | D | Valid to Feb 2028 |
| MDIR-0005172 | PROTEGE Drug Eluting Balloon Catheter (Paclitaxel Elution Balloon Dilatation Catheter) | D | Valid to Jun 2028 |
| MDIR-0005167 | RESTORE DEB (Paclitaxel Releasing PTCA Balloon Catheter) | D | Valid to May 2028 |
| MDIR-0004820 | Rialto PTA Dilatation Balloon Catheter | D | Valid to Feb 2028 |
| MDIR-0004818 | Skinny PTA Dilatation Balloon Catheter | D | Valid to Feb 2028 |
| MDIR-0004617 | SUMMIT CTO (PTCA Balloon Dilatation Catheter) | D | Valid to Feb 2028 |
| MDIR-0004822 | Trift PTA Dilatation Balloon Catheter | D | Valid to Feb 2028 |
| MDIR-0005242 | Vecchio PTCA Balloon Dilatation (PTCA Coronary Dilatation Balloon Catheter) | D | Valid to Jun 2028 |
| MDIR-0000054 | Xlimus Sirolimus Eluting Coronary Stent System | D | Renewal passed |
| MDIR-0004817 | Zeeland PTA Dilatation Balloon Catheter | D | Valid to Feb 2028 |
| MDIR-0008467 | Cardiohealth (Angiographic Closure Pad) | B | Valid to Apr 2030 |
| MDIR-0008468 | Cardiohealth (Balloon Inflation Device) | B | Valid to Apr 2030 |
| MDIR-0008469 | Cardiohealth (Connecting tube) | B | Valid to Apr 2030 |
| MDIR-0008470 | Cardiohealth (Guidewires) | B | Valid to Apr 2030 |
| MDIR-0008472 | Cardiohealth (Hemostasis Valve set) | B | Valid to Apr 2030 |
| MDIR-0008473 | Cardiohealth (Introducer set) | B | Valid to Apr 2030 |
| MDIR-0008474 | Cardiohealth (Manifold) | B | Valid to Apr 2030 |
| MDIR-0009788 | Cardiohealth Guiding Catheter [GC6AL1, GC6AL2, GC6AR1, GC6AR2, GC6EBU30, GC6EBU35, GC6EBU40, GC6IMA, GC6JL35, GC6JL40, GC6JL45,… | B | Valid to Jul 2030 |
| MDIR-0002654 | SCW (Balloon Inflation Device) | B | Renewal passed |
| MDIR-0000882 | SCW Guide Wire | B | Renewal passed |
| MDIR-0000879 | SCW Hemostasis Valve Sets | B | Renewal passed |
| MDIR-0000881 | SCW Introducer Sets | B | Renewal passed |
| MDIR-0000880 | SCW Transradial Introducer Sets | B | Renewal passed |
| MDIR-0009193 | Tianck Balloon Inflation Device | B | Valid to Apr 2030 |
| MDIR-0009195 | Tianck Hemostasis valve sets | B | Valid to Apr 2030 |
| MDIR-0009194 | Tianck Introducer Sets | B | Valid to Apr 2030 |
Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.