Identity
- Trade Name
- Avoximeter EUDAMEDAvoximeter Whole Blood CO-Oximeter FDA UDI
- Generic Name
- Co-oximetry analyser IVD, point-of-care FDA UDI
- Device Name
- Avoximeter Whole Blood Oximeter System - Instrument (International) EUDAMEDAvoximeter Whole Blood CO-Oximeter System - Instrument (Demonstration) FDA UDI
- Model / Reference
- AVOX1000E-INT EUDAMEDAVOX4000D FDA UDI
- Description
- Avoximeter Whole Blood CO-Oximeter System - Instrument (Demonstration) FDA UDI
Identifiers
- Catalog Number
- AVOX4000D FDA UDI
- Primary DI / UDI-DI
- 10711234530016 EUDAMED10711234530252 FDA UDI
- Basic UDI-DI
- B-10711234530016 EUDAMED
- FDA Product Code
- JKS FDA UDI
- EMDN Code
- W0201040101 BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes) EUDAMED
- GMDN Term
- Co-oximetry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.3220 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
EUDAMED
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Avoximeter by Accriva Diagnostics, Inc. — 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-10711234530016 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Accriva Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000009902
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 6c8df0a7-3fd3-406f-b040-e9cf409ff70a 61 fields · synced Jul 9, 2026
- FDA UDI b18a5b06-ccd8-42ac-888b-4b6f902ebb36 35 fields · synced May 25, 2026