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VesPenetrator®
EUDAMEDClass III (EU MDR)
Ref TT-PTCA-PD-BR-ENModel VesPenetrator Balloon Catheter Series
Identity
- Trade Name
- VesPenetrator® EUDAMED
- Device Name
- VesPenetrator® Coronary Dilatation Balloon Catheters EUDAMED
- Model / Reference
- VesPenetrator Balloon Catheter Series EUDAMEDTT-PTCA-PD-BR-EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934184036637 EUDAMED
- Basic UDI-DI
- 069341840PDT6 EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Coronary angioplasty balloon catheter, cutting/scoring
VesPenetrator® by Dongguan Tt Medical, Inc. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Coronary angioplasty balloon catheter, cutting/scoring.
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Sterile PTA Balloon Catheter — Zhejiang Barty Medical Technology Co., Ltd. · Class IIa
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- Kulani™ NC — Meril Life Sciences Pvt. Ltd. · Class III
- Invader PTCA — Alvimedica Tibbi Urunler San. ve Dis Tic. A.S. · Class III
- Wolverine Coronary Cutting Balloon — Boston Scientific · Class III
- Pipit SC — Sahajanand Medical Technologies Limited · Class III
- POT — BrosMed Medical Co., Ltd. · Class III
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 069341840PDT6 | Class III | Active |
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Manufacturer
- Manufacturer
- Dongguan TT Medical, Inc.
- EUDAMED SRN
- CN-MF-000039087
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED ef63fbe9-daa0-496c-9981-4fcf93b2d1e6 61 fields · synced May 25, 2026