Identity
- Trade Name
- Medilite EUDAMED
- Device Name
- Medical Tapes EUDAMED
- Model / Reference
- MD754 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14897122904377 EUDAMED
- Basic UDI-DI
- 489712290mtapeDF EUDAMED
- EMDN Code
- H900299 TAPES, MEDICAL/SURGICAL - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Medilite by Fleming Medical Ltd. — Class I — 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 | 489712290mtapeDF | 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 (1)
- EUDAMED b54cc0a5-e5cf-4e8a-99f4-275365f67c4c 61 fields · synced Jun 19, 2026