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Aidian LF SARS-CoV-2 Ag Test
EUDAMEDClass IVD General (EU MDR)
Ref 154980
by Aidian Oy
Identity
- Trade Name
- Aidian LF SARS-CoV-2 Ag Test EUDAMED
- Device Name
- Aidian LF SARS-CoV-2 Ag Test EUDAMED
- Model / Reference
- 154980 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438115001652 EUDAMED
- Basic UDI-DI
- B-06438115001652 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Aidian LF SARS-CoV-2 Ag Test by Aidian Oy — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06438115001652 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (1)
- EUDAMED 9123e478-5dc5-4d50-9020-0d7e57c15f09 61 fields · synced Jun 18, 2026