Identity
- Trade Name
- UNSTERILE GAUZE BALL EUDAMED
- Device Name
- gauze 13 threads in DOUBLE packaging sterile by ETO EUDAMED
- Model / Reference
- GB30-250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979109835063 EUDAMED
- Basic UDI-DI
- 697240330SGP000001SR EUDAMED
- EMDN Code
- M0201010101 COTTON GAUZE, CUT, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Unsterile Gauze Ball by Xuchang Zhende Surgical Dressing 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 | 697240330SGP000001SR | Class I | Active |
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Manufacturer
- Manufacturer
- Xuchang Zhende Surgical Dressing Co., Ltd
- EUDAMED SRN
- CN-MF-000009222
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d90b02fd-e005-4609-985d-f31abe7e32c8 61 fields · synced Jul 25, 2026