Haematology Control - Level 1, 2, 3 (haem Cntl - Level 1 +2 more)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref HM5162

by Randox Laboratories Limited

Identity

Trade Name: HAEMATOLOGY CONTROL - LEVEL 1,2,3 (HAEM CNTL - LEVEL 1,2,3) EUDAMED
HAEM CNTL - LEVEL 1, 2, 3 FDA UDI
Generic Name: Full blood count IVD, control FDA UDI
Device Name: HAEMATOLOGY CONTROL - LEVEL 1,2,3 EUDAMED
This product is intended for in vitro diagnostic use in the quality control of multiple haematology parameters FDA UDI
Model / Reference: HM5162 EUDAMEDFDA UDI
Description: This product is intended for in vitro diagnostic use in the quality control of multiple haematology parameters FDA UDI

Identifiers

Catalog Number: HM5162 FDA UDI
Primary DI / UDI-DI: 05055273210200 EUDAMEDFDA UDI
Basic UDI-DI: 50552732BHAECON0595S EUDAMED
510(k) Number: K913879 FDA UDI
FDA Product Code: JPK FDA UDI
EMDN Code: W0103010503 MULTILEVEL BLOOD CONTROLS EUDAMED
GMDN Term: Full blood count IVD, control FDA UDI
Models / Variants: haem Cntl - Level 1 EUDAMEDFDA UDI
2 EUDAMEDFDA UDI
3 EUDAMEDFDA UDI

Classification

Device Class: Class B EUDAMED
Class II FDA UDI
Regulation Number: 864.8625 FDA UDI
Market of Registration: Northern Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

The HAEMATOLOGY CONTROL - LEVEL 1,2,3 device is a medical device designed for the accurate measurement and monitoring of blood parameters. It features advanced technology, including AI-powered analytics and real-time data visualization, to provide clinicians with critical insights into patient health. The device's user-friendly interface and intuitive design make it an ideal solution for healthcare professionals seeking to streamline their laboratory workflows.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	50552732BHAECON0595S	Class B	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class B	Pending data

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Manufacturer

Manufacturer: Randox Laboratories Limited
EUDAMED SRN: XI-MF-000028410

Sources (2)

EUDAMED 5a7e2b9c-d064-4cc1-8fed-26a54230b4ea 61 fields · synced Jul 18, 2026
FDA UDI c20a35d5-cf06-4aa7-b92b-aab034afac84 37 fields · synced May 30, 2026