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Spotchem Ez (sp-4430)
EUDAMEDClass IVD General (EU MDR)
Ref 18304Ref 18306Ref 107501
Identity
- Trade Name
- SPOTCHEM EZ (SP-4430) EUDAMED
- Device Name
- SPOTCHEM EZ (SP-4430) EUDAMED
- Model / Reference
- 18304 EUDAMED18306 EUDAMED107501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-18304G8 EUDAMEDD-18306GC EUDAMED04987486034551 EUDAMED
- Basic UDI-DI
- B-18304G8 EUDAMEDB-18306GC EUDAMED4987486BC0107501GJ EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass A EUDAMED
- Market of Registration
- Italy EUDAMEDFinland EUDAMEDIreland 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
Spotchem Ez (sp-4430) by ARKRAY Factory, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-18304G8 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-18304G8 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (3)
- EUDAMED 344282bb-853c-4e3f-b3c9-9f28c692fbd9 61 fields · synced Jul 23, 2026
- EUDAMED fd5e515b-8c5d-411b-9a1a-ce279823c58c 61 fields · synced May 19, 2026
- EUDAMED 2250be1d-f85d-42ce-828f-7d947fccb701 61 fields · synced May 19, 2026