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iCLAS™ Shaped Stylet Accesory
EUDAMEDClass I (EU MDR)
Ref 109-0014-013Model LARGE CIRCLE 90, 35-8-15
Identity
- Trade Name
- iCLAS™ Shaped Stylet Accesory EUDAMED
- Device Name
- iCLAS™ Shaped Stylet Accessory EUDAMED
- Model / Reference
- LARGE CIRCLE 90, 35-8-15 EUDAMED109-0014-013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-109-0014-013ST EUDAMED
- Basic UDI-DI
- B-109-0014-013ST EUDAMED
- EMDN Code
- C020380 ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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™ Shaped Stylet Accesory by Adagio Medical, Inc. — Class I — 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-109-0014-013ST | Class I | 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 e11c7db2-ef21-4e1f-b8d4-2af80a3bff00 61 fields · synced Jun 19, 2026