Identity
- Trade Name
- Avoximeter EUDAMEDAvoximeter Whole Blood Oximeter FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, reagent FDA UDI
- Device Name
- Avoximeter 1000E Cuvettes EUDAMEDAvoximeter 1000E Cuvettes 100 cuvettes/box FDA UDI
- Model / Reference
- C100B EUDAMEDFDA UDI
- Description
- Avoximeter 1000E Cuvettes 100 cuvettes/box FDA UDI
Identifiers
- Catalog Number
- C100B FDA UDI
- Primary DI / UDI-DI
- 10711234160022 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10711234160022 EUDAMED
- 510(k) Number
- K922075 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- W0201040185 BLOOD GAS ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Multiple blood gas analyte IVD, reagent 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
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
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
Yes
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-10711234160022 | 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 8ee630cb-cd69-4e23-861c-a510b9f60790 61 fields · synced Jun 8, 2026
- FDA UDI 8e69b3e0-2c7b-43a1-97e3-87c01fc4eaad 36 fields · synced May 30, 2026