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Reference Solution (ref Soln)

EUDAMEDFDA UDI

Class A (EU MDR)

Ref RX4045

by Randox Laboratories Limited

Identity

Trade Name
REFERENCE SOLUTION (REF SOLN) EUDAMED
REF SOLN FDA UDI
Generic Name
Ion selective electrode (ISE) reference solution IVD, reagent FDA UDI
Device Name
REFERENCE SOLUTION (REF SOLN) EUDAMED
This is required for measuring reference electrode potential of an ion selective electrode module. FDA UDI
Model / Reference
RX4045 EUDAMEDFDA UDI
Description
This is required for measuring reference electrode potential of an ion selective electrode module. FDA UDI

Identifiers

Catalog Number
RX4045 FDA UDI
Primary DI / UDI-DI
05055273214338 EUDAMEDFDA UDI
Basic UDI-DI
50552732AREFSOL014LC EUDAMED
FDA Product Code
JJE FDA UDI
EMDN Code
W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
GMDN Term
Ion selective electrode (ISE) reference solution IVD, reagent FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
862.2160 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

No

EUDAMED

Animal Tissues

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Reference Solution (ref Soln) by Randox Laboratories Limited — Class A — 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 (2)

  • EUDAMED f1fbca82-2333-413d-b8e4-855c7ee0be6b 61 fields · synced Jun 19, 2026
  • FDA UDI cb3148b3-7380-4889-9ef1-008d2f6b0a9f 36 fields · synced May 30, 2026