Identity
- Device Name
- Non-sterile gauze ball with X-ray EUDAMED
- Model / Reference
- Φ20 mm-X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973685042358 EUDAMED
- Basic UDI-DI
- 697368504SBQXDN01NX EUDAMED
- EMDN Code
- M0201020202 COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Non-sterile gauze ball with X-ray by Fomed Industries Inc — 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 | 697368504SBQXDN01NX | Class I | 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 bda92398-2221-4d94-b983-566b060a306e 61 fields · synced Jul 10, 2026