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Cardiac Control - Level 3 (crd Control 3)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref CQ10456Ref CQ10431

by Randox Laboratories Limited

Identity

Trade Name
CARDIAC CONTROL - LEVEL 3 (CRD CONTROL 3) EUDAMEDFDA UDI
CARDIAC CONTROL – LEVEL 3 (CRD CONTROL 3) EUDAMED
Generic Name
Multiple cardiac marker IVD, control FDA UDI
Device Name
CARDIAC CONTROL EUDAMED
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. FDA UDI
Model / Reference
CQ10456 EUDAMED
CQ10431 EUDAMEDFDA UDI
Description
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. FDA UDI

Identifiers

Catalog Number
CQ10431 FDA UDI
Primary DI / UDI-DI
05055273217148 EUDAMED
05055273217674 EUDAMEDFDA UDI
Basic UDI-DI
50552732BCRDCON001AS EUDAMED
FDA Product Code
JJY FDA UDI
EMDN Code
W0102152004 CARDIAC MARKER CONTROLS EUDAMED
GMDN Term
Multiple cardiac marker IVD, control FDA UDI

Classification

Device Class
Class B EUDAMED
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Market of Registration
Northern Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Cardiac Control - Level 3 (crd Control 3) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (3)

  • EUDAMED 5db27162-10b7-47f0-a60f-d8228fc1b6d6 61 fields · synced Jul 25, 2026
  • EUDAMED 2010af21-4cf0-4946-ab72-48d648b97d39 61 fields · synced May 17, 2026
  • FDA UDI fa4c6245-cb57-42ca-81d9-8895bf1d6e7d 36 fields · synced May 30, 2026