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UDI Compass
Certificate valid

Snapshot 2026-10-27 · Link to EUDAMED

sinus-SuperFlex-635

UDI-DI 04047199503215Basic UDI-DI 4047199SINSF63596

Class IIb · MDR · optimed Medizinische Instrumente GmbH

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

50066-61-A0-00

EU technical documentation assessment · valid

Notified body: DEKRA Certification GmbH (0124)

Valid from 2026-08-13 · Expiry 2031-08-12

Scope not stated in certificate data.

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

50066-60-00-00

EU quality management system · valid

Notified body: DEKRA Certification GmbH (0124)

Valid from 2026-08-13 · Expiry 2031-08-12

Scope not stated in certificate data.

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

Manufacturer

optimed Medizinische Instrumente GmbH

SRN DE-MF-000021679

DE · Ettlingen

manufacturer

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Canonical device page: /device/sinus-superflex-635-3215 · UDI page: /udi/04047199503215

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