Multi-pole Pulmonary Artery RF Ablation Catheter

Identification

Model: PADN30C10120, PADN35C10120, PADN37C10120, PADN40C10120, PADN45C10120, PADN50C10120
EMDN: K02030199
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

6158488TD01

EU technical documentation assessment · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2025-03-19 · Expiry 2030-03-01

Scope not stated in certificate data.

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

6158488CE01

EU quality management system · valid

Notified body: DEKRA Certification B.V. (0344)

Valid from 2025-05-19 · Expiry 2030-03-01

Scope not stated in certificate data.

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

Manufacturer

SRN CN-MF-000041578

CN · Wuxi, Jiangsu Province

manufacturer

Authorised representative: BioDomi GmbH (DE-AR-000016611)

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