Identity
- Trade Name
- DracoFoam Infekt Pro 10x20 cm, 10 Stück EUDAMED
- Device Name
- DracoFoam Infekt Pro EUDAMED
- Model / Reference
- 14014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262406530734 EUDAMED
- Basic UDI-DI
- 42600558305578 EUDAMED
- Unit of Use DI
- 04262406530598 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 10x20 cm, 10 Stück by Dr. Ausbüttel GmbH & Co. KG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42600558305578 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Dr. Ausbüttel GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005465
Sources (1)
- EUDAMED d0c53468-a98a-4339-b616-56fe394832b5 61 fields · synced Jul 25, 2026