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Polaris® Reading Instrument-2
EUDAMEDFDA UDIClass I (EU MDR)
Ref PAK2-RIModel PAK2
by Sophysa
Identity
- Trade Name
- POLARIS® READING INSTRUMENT-2 EUDAMEDSophysa FDA UDI
- Generic Name
- Cerebrospinal fluid shunt valve programmer FDA UDI
- Device Name
- Polaris® Valve Adjustment kit-2 EUDAMEDPOLARIS READING INSTRUMENT-2 FDA UDI
- Model / Reference
- PAK2 EUDAMEDPAK2-RI EUDAMEDFDA UDI
- Description
- POLARIS READING INSTRUMENT-2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124131666 EUDAMEDFDA UDI
- Basic UDI-DI
- 376012413PAK000UV EUDAMED
- FDA Product Code
- JXG FDA UDI
- EMDN Code
- N0199 ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - OTHER EUDAMED
- GMDN Term
- Cerebrospinal fluid shunt valve programmer FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Polaris® Reading Instrument-2 by Sophysa — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376012413PAK000UV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (2)
- EUDAMED ca9b70dd-c0c2-4712-8312-adb41714a351 61 fields · synced Jun 20, 2026
- FDA UDI aa37c26e-f71d-4934-9b66-17257f4ec2f8 33 fields · synced May 30, 2026