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I.s.e. Diluent (ise Dil)

EUDAMEDFDA UDI

Class A (EU MDR)

Ref RX4049

by Randox Laboratories Limited

Identity

Trade Name
I.S.E. DILUENT (ISE DIL) EUDAMED
ISE DIL FDA UDI
Generic Name
Buffered sample diluent IVD FDA UDI
Device Name
I.S.E. DILUENT (ISE DIL) EUDAMED
The product is intended for use in the measurement of urine samples. FDA UDI
Model / Reference
RX4049 EUDAMEDFDA UDI
Description
The product is intended for use in the measurement of urine samples. FDA UDI

Identifiers

Catalog Number
RX4049 FDA UDI
Primary DI / UDI-DI
05055273214376 EUDAMEDFDA UDI
Basic UDI-DI
50552732AISEDIL011DB EUDAMED
FDA Product Code
JJE FDA UDI
EMDN Code
W0201010185 CHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
GMDN Term
Buffered sample diluent IVD 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

No

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

I.s.e. Diluent (ise Dil) 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 2d3998b4-613d-4602-978e-ead3f1a453ed 61 fields · synced Jul 26, 2026
  • FDA UDI 317afa7a-12c1-4b2a-8a84-00b9ae26246d 36 fields · synced May 30, 2026