Identity
- Trade Name
- Sterile Gauze Sponges EUDAMED
- Device Name
- Sterile Gauze Sponges EUDAMED
- Model / Reference
- FXLSS1720X2012X5S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970101552880 EUDAMED
- Basic UDI-DI
- 697010155SLS001BM EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Sterile Gauze Sponges by Jiangsu Feixia Medical Products Co., 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 | 697010155SLS001BM | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Feixia Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000016183
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 58ab4d1e-57f2-4781-bc06-32c2b3128505 61 fields · synced Jun 19, 2026