Identity
- Trade Name
- Esophageal Warming Balloon Catheter EUDAMED
- Device Name
- Esophageal Warming Balloon Catheter EUDAMED
- Model / Reference
- 109-0004-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-109-0004-001S7 EUDAMED
- Basic UDI-DI
- B-109-0004-001S7 EUDAMED
- EMDN Code
- G0301010101 OESOPHAGEAL BALLOON CATHETERS, LOW PRESSURE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
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
Esophageal Warming Balloon Catheter by Adagio Medical, Inc. — 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-109-0004-001S7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Adagio Medical, Inc.
- EUDAMED SRN
- US-MF-000001129
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (1)
- EUDAMED 5bb06975-37d4-4870-b12a-3dee418e15b8 61 fields · synced Jul 14, 2026