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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Isolator™ Transpolar™ Pen

UDI-DI 10840143910913Basic UDI-DI 08401439000000000000018ZU

Class III · MDR · AtriCure, Inc.

Identification
Model
MLP1/MCR1/MAX3/MAX5
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

MDR 754861

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2025-08-26 · Expiry 2029-12-16

Scope not stated in certificate data.

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

Manufacturer

AtriCure, Inc.

SRN US-MF-000002974

US · Mason

manufacturer

Authorised representative: AtriCure Europe B.V. (NL-AR-000000165)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/isolatortm-transpolartm-pen-0913 · UDI page: /udi/10840143910913

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