Cosmed

FDA UDI

Class II (US FDA UDI)

by C O S M E D Srl

Identity

Trade Name: COSMED FDA UDI
Generic Name: Cardiac stress exercise monitoring system FDA UDI
Device Name: The Quark C12x is a System for ECG and Stress Electrocardiography testing. ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients. FDA UDI
Model / Reference: Quark C12x FDA UDI
Description: The Quark C12x is a System for ECG and Stress Electrocardiography testing. ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients. FDA UDI

Identifiers

Primary DI / UDI-DI: 18052400180263 FDA UDI
510(k) Number: K000404 FDA UDI
FDA Product Code: MWI FDA UDI
GMDN Term: Cardiac stress exercise monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2300 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

FDA UDI

Category: Cardiac stress exercise monitoring system

Cosmed by C O S M E D Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K000404 also covers:

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: C O S M E D Srl

Sources (1)

FDA UDI 6c6022d3-fd29-4cf1-90f9-0c771bb350c5 35 fields · synced May 30, 2026