← Back to catalogue
Pressio® Icp & Ict Monitoring Kit, Parenchymal With Bolt
EUDAMEDFDA UDIClass III (EU MDR)
Ref PSO-PTT
by Sophysa
Identity
- Trade Name
- PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL WITH BOLT EUDAMEDSophysa FDA UDI
- Generic Name
- Intracerebral sensor catheter, short-term FDA UDI
- Device Name
- PRESSIO® ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING EUDAMEDPRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING FDA UDI
- Model / Reference
- PSO-PTT EUDAMEDFDA UDI
- Description
- PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760124131765 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760124131765 EUDAMED
- 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
- France 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Pressio® Icp & Ict Monitoring Kit, Parenchymal With Bolt 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-03760124131765 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sophysa
- EUDAMED SRN
- FR-MF-000002870
Sources (2)
- EUDAMED db7f75c4-9944-46e5-9e64-f9163e39d6e5 61 fields · synced Jun 19, 2026
- FDA UDI 6e8f98d5-00a1-4270-b91e-ff17c610f169 33 fields · synced May 30, 2026