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iVascular oceanus 35
EUDAMEDClass IIa (EU MDR)
Ref BPPC35200500060Model oceanus 35
Identity
- Trade Name
- iVascular oceanus 35 EUDAMED
- Device Name
- iVascular oceanus 35 EUDAMED
- Model / Reference
- oceanus 35 EUDAMEDBPPC35200500060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435387317014 EUDAMED
- Basic UDI-DI
- 84353873oceanus356A EUDAMED
- Direct Marketing DI
- 08435387317014 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iVascular oceanus 35 by Life Vascular Devices Biotech, S.L. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 84353873oceanus356A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Life Vascular Devices Biotech, S.L.
- EUDAMED SRN
- ES-MF-000019783
Sources (1)
- EUDAMED 723dabc8-882d-4db6-8be0-46cc17354b98 61 fields · synced Sep 30, 2026