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Pressio® Monitoring Kit, Parenchymal Tunneling
EUDAMEDFDA UDIClass III (EU MDR)
Ref PSO-PT
by Sophysa
Identity
- Trade Name
- PRESSIO® MONITORING KIT, PARENCHYMAL TUNNELING EUDAMEDSOPHYSA FDA UDI
- Generic Name
- Intracerebral sensor catheter, short-term FDA UDI
- Device Name
- Pressio® Intracranial pressure monitoring Kit, parenchymal tunnelling EUDAMEDPRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING FDA UDI
- Model / Reference
- PSO-PT EUDAMEDFDA UDI
- Description
- PRESSIO ICP MONITORING KIT, PARENCHYMAL TUNNELING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124130782 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760124130782 EUDAMED
- 510(k) Number
- K062584 FDA UDI
- FDA Product Code
- GWM FDA UDI
- EMDN Code
- Z12039001 INTRACRANIAL PRESSURE MEASURING SYSTEMS EUDAMED
- GMDN Term
- Intracerebral sensor catheter, short-term FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Market of Registration
- Hungary EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
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 Conditional FDA UDI
Pressio® Monitoring Kit, Parenchymal Tunneling by Sophysa — Class III — 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-03760124130782 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (2)
- EUDAMED be28bb7f-bb1b-4558-9a9d-cfe6c71e4f9c 61 fields · synced Jun 19, 2026
- FDA UDI 1cb44e5e-0fa5-4fe2-877c-f8cefa2398fc 34 fields · synced May 30, 2026