Identity
- Trade Name
- Avoximeter EUDAMEDAvoximeter Whole Blood Oximeter FDA UDI
- Generic Name
- Co-oximetry analyser IVD, point-of-care FDA UDI
- Device Name
- Avoximeter Whole Blood Oximeter Optical QC Filters EUDAMEDFDA UDI
- Model / Reference
- E-QCYO EUDAMEDFDA UDI
- Description
- Avoximeter Whole Blood Oximeter Optical QC Filters FDA UDI
Identifiers
- Catalog Number
- E-QCYO FDA UDI
- Primary DI / UDI-DI
- 10711234160015 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10711234160015 EUDAMED
- 510(k) Number
- K922075 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- W0201040185 BLOOD GAS ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Co-oximetry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 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
No
EUDAMED
Prescription Use
Yes
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
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-10711234160015 | 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 b4b9185f-1551-4624-8a3c-17387fdf7f7c 61 fields · synced Jun 8, 2026
- FDA UDI 13f1e21a-9776-45de-8457-8d9d70ccf4bb 36 fields · synced May 24, 2026