Identity
- Trade Name
- SPOTCHEM D-03 (SD-4820) EUDAMED
- Device Name
- SPOTCHEM D-03 (SD-4820) EUDAMED
- Model / Reference
- 107505 EUDAMED17703 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486034582 EUDAMEDD-17703GK EUDAMED
- Basic UDI-DI
- 4987486BC0107505GS EUDAMEDB-17703GK EUDAMED
- EMDN Code
- W0201030101 MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Ireland EUDAMEDGermany 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 D-03 (sd-4820) by ARKRAY Factory, Inc. — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 4987486BC0107505GS | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 4987486BC0107505GS | Class A | 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 (2)
- EUDAMED 3f0026f1-17f0-43aa-a08e-7e7f0b95fa49 61 fields · synced Jul 14, 2026
- EUDAMED 97c27857-7f62-4f8b-9161-ece7addd9958 61 fields · synced May 18, 2026