Identity
- Trade Name
- Sterile Gauze EUDAMED
- Device Name
- Sterile Gauze Sponges EUDAMED
- Model / Reference
- TX0199 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953102624824 EUDAMED
- Basic UDI-DI
- 69531026GSF0501ASS3L EUDAMED
- EMDN Code
- M0201020101 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 by Taizhou Xinkang Medical Materials 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 | 69531026GSF0501ASS3L | Class I | Active |
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Manufacturer
- Manufacturer
- Taizhou Xinkang Medical Materials Co., Ltd
- EUDAMED SRN
- CN-MF-000012941
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 1d7b8a8b-1e77-4d8c-b1fe-7d3afb34b7b7 61 fields · synced Jun 19, 2026