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Cardiac Function Laboratory

FDA UDI

Class II (US FDA UDI)

by Cd Leycom BV

Identity

Trade Name
Cardiac Function Laboratory FDA UDI
Generic Name
Cardiac mapping system FDA UDI
Device Name
Inca PV loop system for the measurement of cardiac function and performance. FDA UDI
Model / Reference
CFL-M Inca FDA UDI
Description
Inca PV loop system for the measurement of cardiac function and performance. FDA UDI

Identifiers

Catalog Number
CDL001 FDA UDI
Primary DI / UDI-DI
08717953256645 FDA UDI
510(k) Number
K003020 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Cardiac mapping system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

No

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

Yes

FDA UDI

Category: Cardiac mapping system

Cardiac Function Laboratory by Cd Leycom BV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cd Leycom BV

Sources (1)

  • FDA UDI 9b731f6e-c3af-46ce-8e51-51a0495c568c 35 fields · synced May 30, 2026