Identity
- Trade Name
- DUALSAN Pelote DX EUDAMED
- Device Name
- Dualsan PELOTA cuscinetto contenimento ernia EUDAMED
- Model / Reference
- 5N5308X00AA01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382241171 EUDAMED
- Basic UDI-DI
- 8054382245N5308TH EUDAMED
- EMDN Code
- Y060499 ABDOMINAL ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
DUALSAN Pelote DX by Dual Sanitaly S.p.A. SB — 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 | 8054382245N5308TH | Class I | Active |
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Manufacturer
- Manufacturer
- Dual Sanitaly S.p.A. SB
- EUDAMED SRN
- IT-MF-000052906
Sources (1)
- EUDAMED 91b56b59-c594-426b-b8bc-3eaa6d0f9b86 61 fields · synced Oct 6, 2026