Identity
- Device Name
- COBRA-OS Kit EUDAMED
- Model / Reference
- F01CK1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10628678061047 EUDAMED
- Basic UDI-DI
- 628678061003HN EUDAMED
- EMDN Code
- C019009 AORTIC OCCLUSION SYSTEMS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- Temporary occlusion of large vessels EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
COBRA-OS Kit by Front Line Medical Technologies Inc. — Class III — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201652 | Class III | Active |
| EUDAMED | European Union | CE/MDR | 628678061003HN | Class III | Active |
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Manufacturer
- Manufacturer
- Front Line Medical Technologies Inc.
- EUDAMED SRN
- CA-PR-000040210
Sources (2)
- EUDAMED f8e39274-b517-4bfc-861a-349ada5b25a2 61 fields · synced Jul 9, 2026
- FDA 510(k) K201652 1 fields · synced May 18, 2026