Identity
- Trade Name
- AUTION Sticks 10PA EUDAMED
- Device Name
- AUTION Sticks 10PA EUDAMED
- Model / Reference
- 73524 EUDAMED73621 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-73524HP EUDAMEDD-73621HN EUDAMED
- Basic UDI-DI
- B-73524HP EUDAMEDB-73621HN EUDAMED
- EMDN Code
- W0101060205 URINE MULTI-CONSTITUENT TEST STRIPS (AUTOMATED) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMEDRomania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
AUTION Sticks 10PA by ARKRAY Factory, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-73524HP | 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 (2)
- EUDAMED 55cf32e1-3694-4dcf-a985-c488eb43f83b 61 fields · synced Jul 19, 2026
- EUDAMED a9dffc5d-6d1b-4950-aae3-b2317fa23b80 61 fields · synced May 18, 2026