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Two bi-laminated and waterproof non-woven sleeve cover with cuffs
EUDAMEDClass I (EU MDR)
Ref 12.D4000.00Model Non-woven sleeve cover
Identity
- Trade Name
- Two bi-laminated and waterproof non-woven sleeve cover with cuffs EUDAMED
- Model / Reference
- Non-woven sleeve cover EUDAMED12.D4000.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08032248831025 EUDAMED
- Basic UDI-DI
- 8032248831019X EUDAMED
- Direct Marketing DI
- 08032248831025 EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Two bi-laminated and waterproof non-woven sleeve cover with cuffs by Delta Med Spa — 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 | 8032248831019X | Class I | Active |
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Manufacturer
- Manufacturer
- Delta Med SPA
- EUDAMED SRN
- IT-MF-000027962
Sources (1)
- EUDAMED 11e2f43e-5743-401d-b5ce-5af545c3e399 61 fields · synced Jun 18, 2026