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Human Precision Control - Level 2 (hum Prec Control 2)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref UN1557

by Randox Laboratories Limited

Identity

Trade Name
HUMAN PRECISION CONTROL - LEVEL 2 (HUM PREC CONTROL 2) EUDAMEDFDA UDI
Generic Name
Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
Device Name
HUMAN PRECISION CONTROL EUDAMED
Model / Reference
UN1557 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
05055273206807 EUDAMEDFDA UDI
Basic UDI-DI
50552732BHUPNCN127PL EUDAMED
FDA Product Code
OHQ FDA UDI
EMDN Code
W0101050102 UNASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
GMDN Term
Multiple-type clinical chemistry analyte profile 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

No

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

Human Precision Control - Level 2 (hum Prec Control 2) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED 4b37c934-0d42-42aa-ae3e-2ee718ede891 61 fields · synced Jun 20, 2026
  • FDA UDI 46eb0ce5-9497-4955-8c9e-ef6d0b4b21b0 32 fields · synced May 30, 2026