← Back to catalogue
Adagio iCLAS™ Shaped Stylets
EUDAMEDClass I (EU MDR)
Ref 109-0014-010Model LARGE FLUTTER
Identity
- Trade Name
- Adagio iCLAS™ Shaped Stylets EUDAMED
- Device Name
- iCLAS™ Shaped Stylet Accessory EUDAMED
- Model / Reference
- LARGE FLUTTER EUDAMED109-0014-010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-109-0014-010SM EUDAMED
- Basic UDI-DI
- B-109-0014-010SM 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
Adagio iCLAS™ Shaped Stylets 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-109-0014-010SM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Adagio Medical, Inc.
- EUDAMED SRN
- US-MF-000001129
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (1)
- EUDAMED 7f85b3a4-263d-47b7-b893-f2bea22fb76f 61 fields · synced Jun 18, 2026