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iVascular oceanus 18
EUDAMEDClass IIa (EU MDR)
Ref BPPC18170200080Model oceanus 18
Identity
- Trade Name
- iVascular oceanus 18 EUDAMED
- Device Name
- iVascular oceanus 18 EUDAMED
- Model / Reference
- oceanus 18 EUDAMEDBPPC18170200080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435387318134 EUDAMED
- Basic UDI-DI
- 84353873oceanus186A EUDAMED
- Direct Marketing DI
- 08435387318134 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 18 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 | 84353873oceanus186A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Life Vascular Devices Biotech, S.L.
- EUDAMED SRN
- ES-MF-000019783
Sources (1)
- EUDAMED cdcf186e-698b-4d23-b958-8b1116db7f9f 61 fields · synced Oct 1, 2026