Identity
- Trade Name
- DracoFoam Infekt Pro 5x5 cm, 10 Stück EUDAMED
- Device Name
- DracoFoam Infekt Pro EUDAMED
- Model / Reference
- 14012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262406530703 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
DracoFoam Infekt Pro 5x5 cm, 10 Stück by Dr. Ausbüttel GmbH & Co. KG — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 36231783-2d0a-4b9f-a861-f88217ab2c56 61 fields · synced Jun 19, 2026