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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

FlexCath Cross Transseptal Solution

UDI-DI 00850027837918Basic UDI-DI 0850027837ACQCROSSP3

Class III · MDR · Acutus Medical, Inc.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

1000166386

EU technical documentation assessment · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2024-02-22 · Expiry 2029-02-21

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

1000165613

EU quality management system · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2024-02-22 · Expiry 2027-11-14

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Acutus Medical, Inc.

SRN US-MF-000019413

US · Carlsbad

manufacturer

Authorised representative: MDSS GmbH (DE-AR-000005430)

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Showing 12 of 21 other UDI-DIs.

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Canonical device page: /device/flexcath-cross-transseptal-solution-7918 · UDI page: /udi/00850027837918

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