Identity
- Trade Name
- Ombra* EUDAMED
- Device Name
- Ombra* Table Top Compressor, 230 Volt Euro Plug EUDAMED
- Model / Reference
- 105511 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00762860055117 EUDAMED
- Basic UDI-DI
- B-00762860055117 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Ombra* by Trudell Medical International — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-00762860055117 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Trudell Medical International
- EUDAMED SRN
- CA-MF-000009860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c94ab043-8c08-4168-a18e-f8ac90ed8493 61 fields · synced May 23, 2026