Identity
- Trade Name
- Mediset EUDAMED
- Device Name
- Mouthcare Pack EUDAMEDDressing set EUDAMED
- Model / Reference
- MD411 EUDAMEDMD400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897122902116 EUDAMED04897122902215 EUDAMED
- Basic UDI-DI
- B-04897122902116 EUDAMEDB-04897122902215 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I 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
Mediset by Fleming Medical Ltd. — Class I — 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-04897122902116 | Class I | 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 ad507fcd-c797-4b6f-988d-2e5832340208 61 fields · synced Jul 13, 2026
- EUDAMED 3f0895d5-bb3c-4b34-b003-e61bc2ad4027 61 fields · synced May 18, 2026