Identity
- Trade Name
- KROMA iT Automatic Immunological Analyzer EUDAMED
- Device Name
- KROMA iT Automatic Immunological Analyzer EUDAMED
- Model / Reference
- 3800050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 8435287393101 EUDAMED
- Basic UDI-DI
- 843528739310HM EUDAMED
- Direct Marketing DI
- 8435287393101 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
KROMA iT Automatic Immunological Analyzer by Linear Chemicals S.L.U — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 843528739310HM | Class A | Active |
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Manufacturer
- Manufacturer
- Linear Chemicals S.L.U
- EUDAMED SRN
- ES-MF-000003284
Sources (1)
- EUDAMED 37640e2b-0eb0-4913-bb93-bdb6575daa43 61 fields · synced Jun 18, 2026