Identity
- Trade Name
- Sterile Gauze Sponges EUDAMED
- Device Name
- Sterile Gauze Sponges EUDAMED
- Model / Reference
- FXLSS2020X4004X5S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970101553238 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
Category: Intranasal splint, non-biodegradable
Sterile Gauze Sponges by Jiangsu Feixia Medical Products Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Intranasal splint, non-biodegradable.
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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 6c8c4497-210a-455d-9c1e-211e70834eef 61 fields · synced Jun 18, 2026