Identity
- Trade Name
- Gauze EUDAMED
- Device Name
- Wound Dressing EUDAMED
- Model / Reference
- CR-FL01 EUDAMEDCR-SW04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974567741208 EUDAMED
- Basic UDI-DI
- 697456774FA-1060DW EUDAMED
- EMDN Code
- M0201010102 COTTON GAUZES, CUT, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Gauze by Wuxi Emsrun Technology 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 | 697456774FA-1060DW | Class I | Active |
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Manufacturer
- Manufacturer
- Wuxi Emsrun Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008968
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 50c5ee30-3462-4124-9bd8-d1fec0612dc3 61 fields · synced Jul 9, 2026