Identity
- Trade Name
- Non Woven Balls EUDAMED
- Device Name
- Sterile non-woven balls 35mm (20x20) EUDAMED
- Model / Reference
- 20013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391516466974 EUDAMED
- Basic UDI-DI
- 539151646GSMNSNWW2 EUDAMED
- EMDN Code
- M0202010101 NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Non Woven Balls by GS Medical — 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 | 539151646GSMNSNWW2 | Class I | Active |
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Manufacturer
- Manufacturer
- GS Medical
- EUDAMED SRN
- IE-MF-000010064
Sources (1)
- EUDAMED 1add2673-d63d-41ee-90ea-d9224fc491ec 61 fields · synced Jul 17, 2026