Regulatory

EU MDR Public Device Information

Pursuant to Article 9 of Regulation EU 2021 2226

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Manufacturer Information

Legal Manufacturer: Profusa, Inc.

Registered Address: 626 Bancroft Way, Ste A, Berkeley CA 94710 USA

Single Registration Number (SRN): US-MF-000050885

Notified Body: GMED SAS NB 0459

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Device Identification Information

Information required under MDR Annex VI Part A Section 2

Device Trade Name: Lumee Oxygen Platform

Basic UDI-DI: 08600146656LUMEEOXYGENPLT

Device Risk Class: IIb

Intended Purpose: Subcutaneous tissue oxygen monitoring system for continuous measurement of local tissue oxygen levels

Sterile: Yes

Implantable: Yes

Single Use: Yes

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Regulatory Status

The device is undergoing conformity assessment under Regulation EU 2017 745.

CE certification status: Under review with GMED SAS.

Information will be updated following certification and EUDAMED full functionality.