Identity
- Trade Name
- WeCheck for S onyx EUDAMED
- Device Name
- WeCheck for S onyx EUDAMED
- Model / Reference
- 109504 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486044604 EUDAMED
- Basic UDI-DI
- 4987486BC0109504H6 EUDAMED
- EMDN Code
- W020106019082 VARIOUS DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
WeCheck for S onyx 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 | 4987486BC0109504H6 | 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 a30ae548-d5c2-4372-966f-e67f692feb1b 61 fields · synced Jul 28, 2026