Skip to content
UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

Extracalm

UDI-DI 05420013500482Basic UDI-DI 5420013Extracalm01KL

Class IIa · MDR · Flen Health Pharma

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

2253359CE03

EU quality management system · valid

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

Valid from 2026-06-03 · Expiry 2027-11-01

Scope not stated in certificate data.

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

Manufacturer

Flen Health Pharma

SRN BE-MF-000000258

BE · Kontich

manufacturer

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/extracalm-0482 · UDI page: /udi/05420013500482

Scan an inventory CSV