Identity
- Trade Name
- Afinion 2 EUDAMED
- Device Name
- Afinion 2 EUDAMED
- Model / Reference
- 1116770 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07070060014418 EUDAMED
- Basic UDI-DI
- 7070060AFI00013T EUDAMED
- Direct Marketing DI
- 07070060014418 EUDAMED
- 510(k) Number
- K214117 FDA 510(k)
- FDA Product Code
- LCP FDA 510(k)
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7470 FDA 510(k)
- Regulation Number
- 864.7470 FDA 510(k)
- Market of Registration
- Norway EUDAMED
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
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
New Device
No
EUDAMED
Afinion 2 by Abbott Diagnostics Technologies AS — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K214117 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 7070060AFI00013T | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Diagnostics Technologies AS
- EUDAMED SRN
- NO-MF-000001423
Sources (2)
- EUDAMED 0edd037e-1a70-44f7-9b61-6305f0db19a9 61 fields · synced Jul 18, 2026
- FDA 510(k) K214117 24 fields · synced May 18, 2026