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UDI Compass
Certificate valid

Snapshot 2026-10-12 · Link to EUDAMED

heracure 3D

UDI-DI +EINN5220188Basic UDI-DI ++EINNCPFK9C

Class III · MDR · INNOTERE GmbH

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

IZ 1037386-1

EU technical documentation assessment · unknown

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2025-09-08 · Expiry 2028-06-01

Scope not stated in certificate data.

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

HZ 1037386-1

EU quality management system · valid

Notified body: TÜV Rheinland LGA Products GmbH (0197)

Valid from 2023-06-02 · Expiry 2028-06-01

Scope not stated in certificate data.

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

Manufacturer

INNOTERE GmbH

SRN DE-MF-000006515

DE · Radebeul

manufacturer

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Canonical device page: /device/heracure-3d-0188 · UDI page: /udi/%2BEINN5220188

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