Identity
- Trade Name
- GALAXIAS EUDAMEDGalaxias - Paracalli ovali EUDAMED
- Device Name
- STERILE PATCH FOR ABRASIONS AND BURNS EUDAMEDPROTECTIVE PLASTER FOR CALLUSES EUDAMED
- Model / Reference
- CLST004627 EUDAMEDPCL004542 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05202378004627 EUDAMED05202378004542 EUDAMED
- Basic UDI-DI
- B-05202378004627 EUDAMED8017990PCLH6 EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMEDM0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDGreece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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
Galaxias by Eurosirel Spa — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05202378004627 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05202378004627 | Class I | Active |
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Manufacturer
- Manufacturer
- Eurosirel Spa
- EUDAMED SRN
- IT-MF-000005982
Sources (2)
- EUDAMED 1276b9d6-cfa7-4ec3-8d6d-235b397d6c7d 61 fields · synced Oct 6, 2026
- EUDAMED 8955986a-92e4-420b-802a-6e7bc07d0296 61 fields · synced May 17, 2026