Identity
- Trade Name
- SOPHY® READING INSTRUMENT EUDAMEDSophysa FDA UDI
- Generic Name
- Cerebrospinal fluid shunt valve programmer FDA UDI
- Device Name
- SOPHY® ADJUSTMENT KIT EUDAMEDSOPHY READING INSTRUMENT FDA UDI
- Model / Reference
- SAK-RI EUDAMEDFDA UDI
- Description
- SOPHY READING INSTRUMENT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124131956 EUDAMEDFDA UDI
- Basic UDI-DI
- 376012413SAK000W4 EUDAMED
- 510(k) Number
- K013488 FDA UDI
- 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
- Hungary 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
Yes
FDA UDI
MR Unsafe FDA UDI
Sophy® Reading Instrument 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 | 376012413SAK000W4 | 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 557fffe4-fe88-4627-aa93-4c08bc73ca9b 61 fields · synced Jun 18, 2026
- FDA UDI c83bced9-b748-4cd7-9aac-f98915394908 34 fields · synced May 30, 2026