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iVascular oceanus 18
EUDAMEDClass IIa (EU MDR)
Ref BPPC18170200120Model oceanus 18
Identity
- Trade Name
- iVascular oceanus 18 EUDAMED
- Device Name
- iVascular oceanus 18 EUDAMED
- Model / Reference
- oceanus 18 EUDAMEDBPPC18170200120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435387318141 EUDAMED
- Basic UDI-DI
- 84353873oceanus186A EUDAMED
- Direct Marketing DI
- 08435387318141 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
Category: Peripheral angioplasty balloon catheter, basic
iVascular oceanus 18 by Life Vascular Devices Biotech, S.L. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Peripheral angioplasty balloon catheter, basic.
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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 ed2a7eab-0602-4a29-9fd2-01e6a2763986 61 fields · synced Jul 28, 2026