Sophysa

FDA UDI

Class II (US FDA UDI)

by Sophysa SA

Identity

Trade Name: Sophysa FDA UDI
Generic Name: Intracerebral sensor catheter, short-term FDA UDI
Device Name: PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING FDA UDI
Model / Reference: PSO-PTT FDA UDI
Description: PRESSIO ICP & ICT MONITORING KIT, PARENCHYMAL TUNNELING FDA UDI

Identifiers

Primary DI / UDI-DI: 03760124132915 FDA UDI
FDA Product Code: GWM FDA UDI
GMDN Term: Intracerebral sensor catheter, short-term FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1620 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Intracerebral sensor catheter, short-term

Sophysa by Sophysa SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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NEUROVENT-P-TEMP — RAUMEDIC AG · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Sophysa SA

Sources (1)

FDA UDI 0d2be4c3-ce1a-460b-bc34-82d046f62331 33 fields · synced May 31, 2026