Identity
- Trade Name
- Mediswab EUDAMED
- Device Name
- Non-woven swabs EUDAMED
- Model / Reference
- MD301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14897122906364 EUDAMED
- Basic UDI-DI
- 489712290SwabXJ EUDAMED
- Unit of Use DI
- 04897122906367 EUDAMED
- EMDN Code
- M0202030102 NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE 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
Mediswab 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 | 489712290SwabXJ | 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 890fb7ae-bd4d-4363-a314-7f3a59d24f78 61 fields · synced Jun 18, 2026