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UDI Compass
Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

FlexCath Cross Transseptal Solution with Flex Sheath

UDI-DI 00850027837956Basic UDI-DI 0850027837FLEXX7

Class III · MDR · Acutus Medical, Inc.

Identification
Model
222852
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

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.

1000131095

EU technical documentation assessment · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2023-08-21 · Expiry 2028-08-20

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)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/flexcath-cross-transseptal-solution-with-flex-sheath-7956 · UDI page: /udi/00850027837956

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