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Eurotrol epoc Calibration Verification Fluids
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 267.000.005
Identity
- Trade Name
- Eurotrol epoc Calibration Verification Fluids EUDAMEDEurotrol® epoc® Calibration Verification Fluids FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
- Device Name
- Eurotrol epoc Calibration Verification Fluids EUDAMEDEurotrol® epoc® Calibration Verification Fluids 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® Calibration Verification Fluids 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
- 267.000.005 EUDAMEDFDA UDI
- Description
- Eurotrol® epoc® Calibration Verification Fluids 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® Calibration Verification Fluids 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
- 267.000.005 FDA UDI
- Primary DI / UDI-DI
- D-267.000.005EB EUDAMED08718734960805 FDA UDI
- Basic UDI-DI
- B-267.000.005EB 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 EUDAMEDClass 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 Calibration Verification Fluids 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-267.000.005EB | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Eurotrol B.V.
- EUDAMED SRN
- NL-MF-000005790
Sources (2)
- EUDAMED 41b9956c-5be7-4afd-96f8-f4cc79ae1d46 61 fields · synced Oct 6, 2026
- FDA UDI a8ea35c5-a816-4e46-9c73-da51981ed07f 35 fields · synced May 30, 2026