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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

NeuroSpeed PTA Balloon Catheter

UDI-DI 04260650332036Basic UDI-DI 426065033NeuroSpeedNR

Class III · MDR · Acandis GmbH

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

1000331236

EU quality management system · unknown

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2026-08-06 · Expiry 2028-03-22

Scope not stated in certificate data.

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

1000269464

EU technical documentation assessment · unknown

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2025-10-30 · Expiry 2028-08-31

Scope not stated in certificate data.

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

Manufacturer

Acandis GmbH

SRN DE-MF-000006259

DE · Pforzheim

manufacturer

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Canonical device page: /device/neurospeed-pta-balloon-catheter-2036 · UDI page: /udi/04260650332036

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