Identity
- Trade Name
- Medigauze EUDAMED
- Device Name
- Swabs Gauze EUDAMED
- Model / Reference
- MD304 EUDAMEDMD305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14897122906333 EUDAMED14897122906340 EUDAMED
- Basic UDI-DI
- 489712290gauzeBA EUDAMED
- Unit of Use DI
- 04897122906336 EUDAMED04897122906343 EUDAMED
- EMDN Code
- M0201020102 COTTON GAUZES, FOLDED, 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
Medigauze 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 | 489712290gauzeBA | 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 842bacfc-9050-4dd6-8312-be9f26ac806f 61 fields · synced Jul 30, 2026
- EUDAMED 04961c5d-efeb-4fcd-82c2-0dfaa6b9a147 61 fields · synced May 19, 2026