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Ovation iX™ Iliac Limb Stent Graft
EUDAMEDClass III (EU MDR)
Ref TV-IL1410100-I
Identity
- Trade Name
- Ovation iX™ Iliac Limb Stent Graft EUDAMED
- Device Name
- Ovation iX™ Iliac Limb Stent Graft EUDAMED
- Model / Reference
- TV-IL1410100-I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850007370534 EUDAMED
- Basic UDI-DI
- B-00850007370534 EUDAMED
- EMDN Code
- P07040199 VASCULAR ENDOPROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Ovation iX™ Iliac Limb Stent Graft by Endologix LLC — 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-00850007370534 | Class III | Active |
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Manufacturer
- Manufacturer
- Endologix LLC
- EUDAMED SRN
- US-MF-000010202
- Authorised Representative
- Endologix International Holdings B.V. NL-AR-000006044
Sources (1)
- EUDAMED 1a8cb21c-50b7-400d-a65a-2c6594c398bf 61 fields · synced Jun 19, 2026