Identity
- Trade Name
- Medifoam EUDAMED
- Device Name
- Self-Adhesive Foam Dressing EUDAMEDNon-Adhesive Foam Heel Dressing EUDAMED
- Model / Reference
- MD1388/1 EUDAMEDMD1384/1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897122903137 EUDAMED04897122903113 EUDAMED
- Basic UDI-DI
- B-04897122903137 EUDAMEDB-04897122903113 EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Medifoam by Fleming Medical Ltd. — Class IIb — MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04897122903137 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fleming Medical Ltd.
- EUDAMED SRN
- CN-MF-000014750
- Authorised Representative
- Fleming Medical IE-AR-000012571
Sources (2)
- EUDAMED adf2cb50-f1eb-499c-a767-c29a999e94f7 61 fields · synced Jul 9, 2026
- EUDAMED 123996c8-a6b0-4f61-9658-34d832fb71e7 61 fields · synced May 19, 2026