Identity
- Trade Name
- iCLAS™ Cryoablation Catheter EUDAMED
- Device Name
- iCLAS™ Cryoablation Catheter EUDAMED
- Model / Reference
- 109-0013-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-109-0013-001S9 EUDAMED
- Basic UDI-DI
- B-109-0013-001S9 EUDAMED
- EMDN Code
- C020302 ARRHYTHMOGENIC FOCI CRYOENERGY ABLATION CATHETERS EUDAMED
Classification
- Device Class
- Class III 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
iCLAS™ Cryoablation Catheter by Adagio Medical, Inc. — Class III — 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-109-0013-001S9 | Class III | 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 22c5e519-af32-49df-99a9-11bc6350fbd3 61 fields · synced Jun 18, 2026