Ep-Tracer

FDA UDI

Class II (US FDA UDI)

by CardioTek B.V.

Identity

Trade Name: EP-TRACER FDA UDI
Generic Name: Cardiac electrophysiology analysis system FDA UDI
Device Name: EP-TRACER 102 included in the cart system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. FDA UDI
Model / Reference: 60SYS03 FDA UDI
Description: EP-TRACER 102 included in the cart system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. FDA UDI

Identifiers

Primary DI / UDI-DI: 04260441452639 FDA UDI
510(k) Number: K183266 FDA UDI
FDA Product Code: DQK FDA UDI
GMDN Term: Cardiac electrophysiology analysis system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1425 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac electrophysiology analysis system

Ep-Tracer by CardioTek B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K183266 also covers:

Adapter cables unipolar/ bipolar (set of 10) — CardioTek B.V.
Aluminium carrying case — CardioTek B.V.
EP-TRACER — CardioTek B.V.
EP-TRACER — CardioTek B.V.
EP-TRACER — CardioTek B.V.
EP-TRACER — CardioTek B.V.
EP-TRACER — CardioTek B.V.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: CardioTek B.V.

Sources (1)

FDA UDI 94f039fe-5b21-46e4-8f07-3deb7b287ed3 35 fields · synced May 30, 2026