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17th Sterile gauze swab with x ray, EO
EUDAMEDClass IIa (EU MDR)
Ref 412ASD10-10
Identity
- Trade Name
- 17th Sterile gauze swab with x ray,EO EUDAMED
- Device Name
- Non sterile gauze swab 40s 26x18 EUDAMED
- Model / Reference
- 412ASD10-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978419024150 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
- France 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
17th Sterile gauze swab with x ray, EO 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 8351ccb8-255f-4b62-aff7-0d40e25d4346 61 fields · synced Aug 3, 2026