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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 T12x is an ECG system that is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischeria, rate abnormalities, or features of prognostic value in patients. FDA UDI
Model / Reference
Quark T12x FDA UDI
Description
The Quark T12x is an ECG system that is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischeria, rate abnormalities, or features of prognostic value in patients. FDA UDI

Identifiers

Primary DI / UDI-DI
18052400180287 FDA UDI
510(k) Number
K080141 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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

Similar devices

Also classified as Cardiac stress exercise monitoring system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
C O S M E D Srl

Sources (1)

  • FDA UDI 81bdfef9-1c06-4481-84e9-0cdcde2e8e59 35 fields · synced May 30, 2026