Is this your brand? Sign in to claim ownership.
Sign in to claim this brandCardioTek B.V.
US
Last updated May 30, 2026
What CardioTek B.V. makes
CardioTek B.V. manufactures cardiac electrophysiology analysis systems, including the EP-TRACER devices and associated accessories such as unipolar/bipolar adapter cables and aluminium carrying cases. These systems are designed for electrophysiological studies and mapping procedures in clinical settings.
The company’s portfolio is classified under FDA’s Class II regulatory category and is listed in the FDA’s Unique Device Identifier (UDI) database. The devices are intended for use in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does CardioTek B.V. manufacture?
CardioTek B.V. specializes in cardiac electrophysiology analysis systems, including the EP-TRACER devices. These systems are primarily used for electrophysiological studies and mapping procedures in clinical environments. The company also produces related accessories like unipolar/bipolar adapter cables and aluminium carrying cases to support these systems.
Where is CardioTek B.V. based, and where are its devices intended for use?
CardioTek B.V. is based in the United States. The devices it manufactures, such as the EP-TRACER systems and associated accessories, are specifically intended for use in the U.S. regulatory environment.
In which regulatory registries or databases are CardioTek B.V.’s devices listed?
CardioTek B.V.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability in the healthcare system.
How are CardioTek B.V.’s devices classified under FDA regulations?
CardioTek B.V.’s devices fall under the FDA’s Class II regulatory category. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as cardiac electrophysiology systems used in clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 415868731
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ep-Tracer | 40SYS01 | FDA UDI | Class II | Active |
| Ep-Tracer | 32SYS02 | FDA UDI | Class II | Active |
| Ep-Tracer | 60SYS01 | FDA UDI | Class II | Active |
| Adapter cables unipolar/ bipolar (set of 10) | 03UBC02 | FDA UDI | Class II | Active |
| Aluminium carrying case | 08ACC01 | FDA UDI | Class II | Active |
| Ep-Tracer | 40SYS02 | FDA UDI | Class II | Active |
| Ep-Tracer | 60SYS02 | FDA UDI | Class II | Active |
| Ep-Tracer | 60SYS03 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.