Identity
- Trade Name
- INDAS(STERILE GAUZE SWABS) EUDAMED
- Device Name
- =V18 EUDAMED
- Model / Reference
- 1327126 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972403301562 EUDAMED
- Basic UDI-DI
- 697240330NSGP000001M9 EUDAMED
- EMDN Code
- M0201010102 COTTON GAUZES, CUT, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Indas(sterile Gauze Swabs) 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 | 697240330NSGP000001M9 | 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 44d9b327-692a-4e17-bd19-c0e412ad5b74 61 fields · synced Jul 27, 2026