Identity
- Trade Name
- AutionIDaten (AE-4070) EUDAMED
- Device Name
- AutionIDaten (AE-4070) EUDAMED
- Model / Reference
- 108412 EUDAMED109271 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987486039594 EUDAMED04987486043751 EUDAMED
- Basic UDI-DI
- 4987486BC0108412GR EUDAMED
- EMDN Code
- W020101020102 SEMI-AUTOMATED URINE ANALYSERS 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
AutionIDaten (AE-4070) 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 | 4987486BC0108412GR | 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 e5a506e6-63aa-4ab6-a867-47255eb96fa6 61 fields · synced Jul 29, 2026
- EUDAMED bb74a39d-da34-4fb4-87c5-26d68a376f80 61 fields · synced May 18, 2026