Identity
- Trade Name
- INDIKO PLUS EUDAMED
- Device Name
- INDIKO EUDAMED
- Model / Reference
- 98640000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438153001133 EUDAMED
- Basic UDI-DI
- 6438153BU00187CC EUDAMED
- Direct Marketing DI
- 06438153001133 EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Finland EUDAMED
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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Indiko Plus by Thermo Fisher Scientific Oy — 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 | K110035 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 6438153BU00187CC | Class A | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
- FDA Applicant
- Thermofisher Scientific OY
Sources (2)
- EUDAMED 3a1d2661-ca73-4d00-b07b-ce61c2ee783c 85 fields · synced Jun 18, 2026
- FDA 510(k) K110035 1 fields · synced May 18, 2026