Identity
- Trade Name
- STERILE GAUZE BALL with X-Ray EUDAMED
- Device Name
- Non sterile gauze swab 40s 26x18 EUDAMED
- Model / Reference
- GBX40-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979109834820 EUDAMED
- Basic UDI-DI
- 697240330GP0000014T EUDAMED
- EMDN Code
- M0201010201 COTTON GAUZES, CUT, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa 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
STERILE GAUZE BALL with X-Ray by Xuchang Zhende Surgical Dressing Co., Ltd. — Class IIa — 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 | 697240330GP0000014T | Class IIa | 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 003af9b5-3ada-41af-a360-982d1d613aa6 61 fields · synced Jul 18, 2026