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Pressio® 2 Icp Monitor
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref PSO-4000
by Sophysa
Identity
- Trade Name
- PRESSIO® 2 ICP MONITOR EUDAMEDSophysa FDA UDI
- Generic Name
- Intracranial pressure monitor FDA UDI
- Device Name
- Pressio 2 ICP Monitor EUDAMEDFDA UDI
- Model / Reference
- PSO-4000 EUDAMEDFDA UDI
- Description
- PRESSIO 2 ICP MONITOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124132076 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760124132076 EUDAMED
- FDA Product Code
- GWM FDA UDI
- EMDN Code
- Z12039001 INTRACRANIAL PRESSURE MEASURING SYSTEMS EUDAMED
- GMDN Term
- Intracranial pressure monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Market of Registration
- Romania 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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 Unsafe FDA UDI
Pressio® 2 Icp Monitor by Sophysa — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760124132076 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (2)
- EUDAMED af05494c-8598-416b-aaee-939e34e05c47 61 fields · synced Jun 18, 2026
- FDA UDI 77e48873-e253-4c38-b9e8-8226cb246fdd 33 fields · synced May 30, 2026