Identity
- Trade Name
- SPRAY PLASTER - SÅRPLAST EUDAMED
- Device Name
- AKUTOL™ spray EUDAMED
- Model / Reference
- Z080050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594013705110 EUDAMED
- Basic UDI-DI
- 859401370Z08NJ EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
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
Spray Plaster - Sårplast by AVEFLOR, a.s. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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 | 859401370Z08NJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- AVEFLOR, a.s.
- EUDAMED SRN
- CZ-MF-000003103
Sources (1)
- EUDAMED 9a80affc-9ed5-4a55-bd0e-965174d01515 61 fields · synced Jul 9, 2026