Identity
- Trade Name
- VITUS EUDAMED
- Device Name
- VITUS Paclitaxel Coated PTA Catheter EUDAMED
- Model / Reference
- VIT0200060150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251895630711 EUDAMED
- Basic UDI-DI
- B-04251895630711 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Category: Peripheral angioplasty balloon catheter, basic
Vitus by eucatech AG — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
- Advocate™ — Merit Medical Systems, Inc. · Class II
- Senri — KANEKA Corporation · Class IIa
- Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04251895630711 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- eucatech AG
- EUDAMED SRN
- DE-MF-000005541
Sources (1)
- EUDAMED 1f55ed3d-4fc4-4628-a295-31585e2146b5 61 fields · synced Jun 18, 2026