Identity
- Trade Name
- CSD EUDAMED
- Device Name
- X-ray Detectable Gauze Sponge EUDAMED
- Model / Reference
- C52 EUDAMEDcsd-dmr-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711908310912 EUDAMED
- Basic UDI-DI
- 4711908C5298 EUDAMED
- Direct Marketing DI
- 04711908310912 EUDAMED
- EMDN Code
- M0201020201 COTTON GAUZES, FOLDED, 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Csd by China Surgical Dressings Center 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 | 4711908C5298 | Class IIa | Active |
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Manufacturer
- Manufacturer
- China Surgical Dressings Center Co., Ltd.
- EUDAMED SRN
- TW-MF-000002332
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 978347db-c5a7-4a22-bb98-cf3ea5ecf14a 61 fields · synced May 22, 2026