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Insufflation tubing sets, gas filter, smoke evacuation, heated, sterile

EUDAMED

Class IIb (EU MDR)

Ref UI613

by KARL STORZ SE & Co. KG

Identity

Device Name
Insufflation tubing sets, gas filter, smoke evacuation, heated, sterile EUDAMED
Model / Reference
UI613 EUDAMED

Identifiers

Primary DI / UDI-DI
04048551453650 EUDAMED
Basic UDI-DI
4048551005152U7 EUDAMED
Unit of Use DI
04048551463291 EUDAMED
EMDN Code
Z12029085 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - CONSUMABLES EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Insufflation tubing sets, gas filter, smoke evacuation, heated, sterile by KARL STORZ SE & Co. KG — Class IIb — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
DE-MF-000005723

Sources (1)

  • EUDAMED 55064d1c-a63f-42ae-9e5c-15cbd6f82a72 61 fields · synced Jul 9, 2026