Identity
- Trade Name
- Fomed EUDAMED
- Device Name
- Sterile lap sponges with X-Ray EUDAMED
- Model / Reference
- 13A02, 17A02, 20A02 EUDAMED13A02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973685040392 EUDAMED
- Basic UDI-DI
- 697368504FBDXAS01A3 EUDAMED
- Direct Marketing DI
- 06973685040392 EUDAMED
- EMDN Code
- M0201030201 LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Fomed by Fomed Industries Inc — Class IIa — 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 | 697368504FBDXAS01A3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fomed Industries Inc.
- EUDAMED SRN
- CN-MF-000012944
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED cf757ac0-bec1-4bb3-b3fe-6ff074291431 61 fields · synced May 23, 2026