Identity
- Trade Name
- Medicare EUDAMED
- Device Name
- Burn Gel EUDAMED
- Model / Reference
- MD77 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897122903458 EUDAMED
- Basic UDI-DI
- B-04897122903458 EUDAMED
- EMDN Code
- M04040502 HYDROGEL DRESSINGS, COMBINED WITH OTHER SUBSTANCES 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
Medicare by Fleming Medical Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-04897122903458 | 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 (1)
- EUDAMED bdf1ddcf-8e4e-4012-aca4-5f13a92a1106 61 fields · synced Jun 19, 2026