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I.s.e. Cleaner (ise Cln)

EUDAMEDFDA UDI

Class A (EU MDR)

Ref RX4047

by Randox Laboratories Limited

Identity

Trade Name
I.S.E. CLEANER (ISE CLN) EUDAMED
I.S.E. CLN FDA UDI
Generic Name
Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Device Name
I.S.E. CLEANER (ISE CLN) EUDAMED
The product should be run on a weekly basis to prevent protein build up. FDA UDI
Model / Reference
RX4047 EUDAMEDFDA UDI
Description
The product should be run on a weekly basis to prevent protein build up. FDA UDI

Identifiers

Catalog Number
RX4047 FDA UDI
Primary DI / UDI-DI
05055273214352 EUDAMEDFDA UDI
Basic UDI-DI
50552732AISECLN044EU EUDAMED
FDA Product Code
JJE FDA UDI
EMDN Code
W0201010185 CHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
GMDN Term
Wash/cleaning solution IVD, automated/semi-automated system 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
Not 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

I.s.e. Cleaner (ise Cln) 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 17452463-71ea-40ca-974a-0153dacfc603 61 fields · synced Jun 18, 2026
  • FDA UDI b4942ffe-e409-49c9-b938-f40b50d5afaa 37 fields · synced May 29, 2026