Identity
- Trade Name
- Comprese sterile（EVRIKA） EUDAMED
- Device Name
- Sterile Gauze Swabs EUDAMED
- Model / Reference
- RMNY8X10GS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970101555331 EUDAMED
- Basic UDI-DI
- 697010155SGS0019W EUDAMED
- Unit of Use DI
- 86970101555337 EUDAMED
- EMDN Code
- M0201010101 COTTON GAUZE, CUT, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Comprese sterile（EVRIKA） by Jiangsu Feixia Medical Products 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 | 697010155SGS0019W | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Feixia Medical Products Co., Ltd
- EUDAMED SRN
- CN-MF-000016183
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED d383f744-747d-4acd-8222-2f837fd20f74 61 fields · synced Oct 6, 2026