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Polaris® Valves Electronic Reading Instrument
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref PAK3-ERI
by Sophysa
Identity
- Trade Name
- POLARIS® VALVES ELECTRONIC READING INSTRUMENT EUDAMED
- Device Name
- POLARIS® ELECTRONIC READING INSTRUMENT EUDAMED
- Model / Reference
- PAK3-ERI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760124132403 EUDAMED
- Basic UDI-DI
- 376012413PAK001UX EUDAMED
- EMDN Code
- N0199 ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Polaris® Valves Electronic Reading Instrument by Sophysa — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222422 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 376012413PAK001UX | Class I | Active |
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Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (2)
- EUDAMED bbd40a9f-1d55-4f21-aa0f-462acb0b5534 61 fields · synced Jun 19, 2026
- FDA 510(k) K222422 1 fields · synced May 18, 2026