Identity
- Trade Name
- PRESSIO® MRI SUPPORT EUDAMEDSophysa FDA UDI
- Generic Name
- Intracerebral sensor catheter, short-term FDA UDI
- Device Name
- PRESSIO MRI SUPPORT EUDAMEDMRI SUPPORT FDA UDI
- Model / Reference
- PSO-MRI EUDAMEDFDA UDI
- Description
- MRI SUPPORT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124132007 EUDAMEDFDA UDI
- Basic UDI-DI
- 376012413PSOMRI000DN EUDAMED
- FDA Product Code
- GWM FDA UDI
- EMDN Code
- Z11059099 VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Intracerebral sensor catheter, short-term FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Market of Registration
- Poland 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Pressio® Mri Support 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 | 376012413PSOMRI000DN | 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 745530d0-55cd-4da1-9c1a-7a4add5bdf6e 61 fields · synced Jun 19, 2026
- FDA UDI fd26706f-093f-4dbe-89af-9356820c82b2 33 fields · synced May 29, 2026