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VesTrek™
EUDAMEDClass III (EU MDR)
Ref TT-PTCA-HYB-BR-ENModel VesTrek™ HYB Balloon Catheter Series
Identity
- Trade Name
- VesTrek™ EUDAMED
- Device Name
- VesTrek™ HYB Coronary Dilatation Balloon Catheters EUDAMED
- Model / Reference
- VesTrek™ HYB Balloon Catheter Series EUDAMEDTT-PTCA-HYB-BR-EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934184021558 EUDAMED
- Basic UDI-DI
- 069341840HYBJE 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
VesTrek™ by Dongguan Tt Medical, Inc. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 069341840HYBJE | 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 61fafc0c-2ae7-4e9b-b5ce-f153eb8a9090 61 fields · synced Jun 20, 2026