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DracoFoam Infekt Pro 5x5 cm, Muster 3 Stück

EUDAMED

Class IIb (EU MDR)

Ref 14012-M2

by Dr. Ausbüttel GmbH & Co. KG

Identity

Trade Name
DracoFoam Infekt Pro 5x5 cm, Muster 3 Stück EUDAMED
Device Name
DracoFoam Infekt Pro EUDAMED
Model / Reference
14012-M2 EUDAMED

Identifiers

Primary DI / UDI-DI
04262406530710 EUDAMED
Basic UDI-DI
42600558305578 EUDAMED
Unit of Use DI
04262406530567 EUDAMED
EMDN Code
M04040601 POLYURETHANE DRESSINGS, NON-COMBINED 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

Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial

DracoFoam Infekt Pro 5x5 cm, Muster 3 Stück by Dr. Ausbüttel GmbH & Co. KG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
DE-MF-000005465

Sources (1)

  • EUDAMED 2332e59a-ab4f-47c1-ad64-157053da4c8d 61 fields · synced Jul 21, 2026