Identity
- Trade Name
- PSKT2 - Aurora 2 EUDAMED
- Device Name
- Pikosystems EUDAMED
- Model / Reference
- PSKT-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06414505184655 EUDAMED
- Basic UDI-DI
- 6414505PST5 EUDAMED
- Direct Marketing DI
- 06414505184655 EUDAMED
- EMDN Code
- Y2199 COMMUNICATION AND INFORMATION MANAGEMENT AIDS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PSKT2 - Aurora 2 by Berner Oy — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6414505PST5 | Class I | Active |
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Manufacturer
- Manufacturer
- Berner Oy
- EUDAMED SRN
- FI-MF-000007402
Sources (1)
- EUDAMED 55b51d0c-b60f-4dbc-af3e-714274db320a 61 fields · synced Aug 1, 2026