Identity
- Trade Name
- DUALSAN Pelote SX EUDAMED
- Device Name
- Dualsan PELOTA cuscinetto contenimento ernia EUDAMED
- Model / Reference
- 5N5308X00AA02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054382242703 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 SX 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 c21fa109-bd35-4ce3-9c1b-4ab7c1dcd399 61 fields · synced Oct 6, 2026