Identity
- Trade Name
- ensoETM EUDAMED
- Device Name
- ensoETM EUDAMED
- Model / Reference
- ECD04-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00857915006234 EUDAMED
- Basic UDI-DI
- B-00857915006234 EUDAMED
- EMDN Code
- G0199 ORO-OESOPHAGEAL TUBES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
ensoETM by Attune Medical — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172493 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K172029 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00857915006234 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Attune Medical
- EUDAMED SRN
- US-MF-000033315
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED cb697f72-8461-4048-94ca-e8928c7128dd 85 fields · synced Jun 19, 2026
- FDA 510(k) K172493 1 fields · synced May 18, 2026