Identity
- Trade Name
- SPOTCHEM D-01 (SD-3810) EUDAMED
- Device Name
- SPOTCHEM D-01 (SD-3810) EUDAMED
- Model / Reference
- 107503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486034568 EUDAMED
- Basic UDI-DI
- 4987486BC0107503GN EUDAMED
- EMDN Code
- W0201030101 MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Ireland 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-01 (sd-3810) by ARKRAY Factory, Inc. — 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 | 4987486BC0107503GN | 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 (1)
- EUDAMED 47f980f0-7edb-4440-8416-7f0310ada85e 61 fields · synced Jun 19, 2026