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VesSpiral®
EUDAMEDClass III (EU MDR)
Ref TT-PTCA-VSP-BR-ENModel VesSpiral® Balloon Catheter SeriesRef TT-PTCA-3VSP-BR-ENModel VesSpiral® Ultra Balloon Catheter SeriesRef VSP27530
Identity
- Trade Name
- VesSpiral® EUDAMED
- Device Name
- VesSpiral® Coronary Dilatation Balloon Catheters EUDAMEDVesSpiral® Ultra Coronary Dilatation Balloon Catheters EUDAMED
- Model / Reference
- VesSpiral® Balloon Catheter Series EUDAMEDTT-PTCA-VSP-BR-EN EUDAMEDVesSpiral® Ultra Balloon Catheter Series EUDAMEDTT-PTCA-3VSP-BR-EN EUDAMEDVSP27530 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934184041013 EUDAMED06934184017094 EUDAMED06934184046087 EUDAMED
- Basic UDI-DI
- 069341840VSPLW EUDAMED0693418403VSPAD EUDAMED
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMEDCroatia 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
VesSpiral® 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 | 069341840VSPLW | 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 (3)
- EUDAMED 28fd2a3b-e795-4bb7-a41d-0a8b93840c79 61 fields · synced Sep 30, 2026
- EUDAMED 89a600ce-efeb-42c9-9312-565a487f7542 61 fields · synced May 18, 2026
- EUDAMED 8971dd6a-7605-4093-82be-84831132cd8c 61 fields · synced Sep 30, 2026