Identity
- Trade Name
- Sinaqua x 12 EUDAMED
- Device Name
- Sinaqua EUDAMED
- Model / Reference
- 95500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033976720025 EUDAMED
- Basic UDI-DI
- B-08033976720025 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Sinaqua x 12 by WELCARE INDUSTRIES S.p.A. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08033976720025 | Class IIa | Active |
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Manufacturer
- Manufacturer
- WELCARE INDUSTRIES S.p.A.
- EUDAMED SRN
- IT-MF-000020870
Sources (1)
- EUDAMED b9ebe842-6c02-4823-a4fe-34b0021e98f7 61 fields · synced Aug 2, 2026