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Eurotrol epoc GAS-ISE Metabolites Level 3

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 266.003.010

by Eurotrol B.V.

Identity

Trade Name
Eurotrol epoc GAS-ISE Metabolites Level 3 EUDAMED
Eurotrol epoc GAS-ISE Metabolites FDA UDI
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
Device Name
Eurotrol epoc GAS-ISE Metabolites Level 3 EUDAMED
Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 3 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. FDA UDI
Model / Reference
266.003.010 EUDAMED
Level 3 FDA UDI
Description
Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 3 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. FDA UDI

Identifiers

Catalog Number
266.003.010 FDA UDI
Primary DI / UDI-DI
D-266.003.010EE EUDAMED
08718734960775 FDA UDI
Basic UDI-DI
B-266.003.010EE EUDAMED
510(k) Number
K121468 FDA UDI
FDA Product Code
JJY FDA UDI
EMDN Code
W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
GMDN Term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Market of Registration
Netherlands 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

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Eurotrol epoc GAS-ISE Metabolites Level 3 by Eurotrol B.V. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eurotrol B.V.
EUDAMED SRN
NL-MF-000005790

Sources (2)

  • EUDAMED 691f48cb-00f8-4542-92de-f8d3effcf84b 61 fields · synced Jul 12, 2026
  • FDA UDI b4b09b33-f7a7-41dc-914e-e3873c1acbc1 35 fields · synced May 30, 2026