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System Calibrator

EUDAMEDFDA UDIFDA 510(k)

Class C (EU MDR)

Ref 66300

by Beckman Coulter Ireland Inc.

Identity

Trade Name
System Calibrator EUDAMED
AU FDA UDI
Generic Name
Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
Device Name
System Calibrator EUDAMEDFDA UDI
Model / Reference
66300 EUDAMEDFDA UDI
Description
SYSTEM CALIBRATOR FDA UDI

Identifiers

Primary DI / UDI-DI
15099590131180 EUDAMEDFDA UDI
Basic UDI-DI
15099590266300SS EUDAMED
510(k) Number
K141388 FDA UDI
FDA Product Code
JIX FDA UDI
EMDN Code
W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI

Classification

Device Class
Class C EUDAMED
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
Market of Registration
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

No

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

Yes

FDA UDI

System Calibrator by Beckman Coulter Ireland Inc. — Class C — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Beckman Coulter Ireland Inc.
EUDAMED SRN
IE-MF-000000887

Sources (3)

  • EUDAMED 62b8a3af-3f01-4a57-915e-68b0c60ca4bf 61 fields · synced Oct 6, 2026
  • FDA UDI 124b7448-b430-4816-a2cc-e50224e4437f 34 fields · synced May 30, 2026
  • FDA 510(k) K141388 1 fields · synced May 18, 2026