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UDI Compass
Certificate valid

Snapshot 2026-10-11 · Link to EUDAMED

Occlutech Sizing Balloon

UDI-DI 04260182521854Basic UDI-DI 426018252OSBF4

Class III · MDR · Occlutech GmbH

Identification
Model
—
EMDN
C99
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

51030-61-C0

EU technical documentation assessment · valid

Notified body: DEKRA Certification GmbH (0124)

Valid from 2023-06-29 · Expiry 2028-06-28

Scope not stated in certificate data.

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

51030-60-00-01

EU quality management system · unknown

Notified body: DEKRA Certification GmbH (0124)

Valid from 2026-05-07 · Expiry 2026-10-19

Scope not stated in certificate data.

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

Manufacturer

Occlutech GmbH

SRN DE-MF-000005104

DE · Jena

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/occlutech-sizing-balloon-1854 · UDI page: /udi/04260182521854

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