Identity
- Trade Name
- OSMO STATION (OM-6050) EUDAMED
- Device Name
- OSMO STATION (OM-6050) EUDAMED
- Model / Reference
- 60503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-60503GF EUDAMED
- Basic UDI-DI
- B-60503GF EUDAMED
- EMDN Code
- W02079017 OSMOMETERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Czechia 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
Osmo Station (om-6050) 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-60503GF | 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 (1)
- EUDAMED f2df68e8-e816-41e9-8be8-576593e815b2 61 fields · synced Jul 28, 2026