Aluminium carrying case

FDA UDI

Class II (US FDA UDI)

by CardioTek B.V.

Identity

Trade Name: Aluminium carrying case FDA UDI
Generic Name: Cardiac electrophysiology analysis system FDA UDI
Model / Reference: 08ACC01 FDA UDI

Identifiers

Primary DI / UDI-DI: 04260441450574 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

Aluminium carrying case by CardioTek B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Pure EP - Catheter Input Module — Biosig Technologies · Class II
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Cleared under the same submission

K183266 also covers:

Adapter cables unipolar/ bipolar (set of 10) — 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.
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 d321576a-3362-46c1-abb1-f8c6acbc92ff 33 fields · synced Jun 8, 2026