Identity
- Trade Name
- GALENO EUDAMED
- Device Name
- COMPRESAS ESTÉRILES PLEGADAS DE GASA RECTILÍNEA USO QUIRÚRGICO EUDAMED
- Model / Reference
- 2012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18435081520120 EUDAMED
- Basic UDI-DI
- 84350815CPEEQ3 EUDAMED
- Direct Marketing DI
- 18435081520120 EUDAMED
- EMDN Code
- M0201020101 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Galeno by Ortopedia y Cirugía, S.L. — 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 | 84350815CPEEQ3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ortopedia y Cirugía, S.L.
- EUDAMED SRN
- ES-MF-000016977
Sources (1)
- EUDAMED ce5166a6-399d-4334-b4ce-13e0b5144806 61 fields · synced Jul 14, 2026