No Certificate Found

Snapshot 2026-10-12 · Link to EUDAMED

X8 System (Sleep Profiler, Sleep Profiler PSG2)

UDI-DI 00851113007161Basic UDI-DI 0851113007SP29ACCTH

Class I · MDR · Advanced Brain Monitoring, Inc.

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Identification

Model: —
EMDN: N01010203
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-12 · Link to EUDAMED

Manufacturer

Advanced Brain Monitoring, Inc.

SRN US-MF-000011252

US · Carlsbad, CA

manufacturer

Authorised representative: MPS Medical Product Service GmbH (DE-AR-000005009)

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X8 System (Sleep Profiler, Sleep Profiler PSG2) 00850015266836
X8 System (Sleep Profiler, Sleep Profiler PSG2) 00850015266805
X8 System (Sleep Profiler, Sleep Profiler PSG2) 00851113007215
X8 System (Sleep Profiler, Sleep Profiler PSG2) 00851113007178

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/x8-system-sleep-profiler-sleep-profiler-psg2-7161 · UDI page: /udi/00851113007161

All devices from Advanced Brain Monitoring, Inc.

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