← Back to catalogue
iVascular oceanus 35
EUDAMEDClass IIa (EU MDR)
Ref BPPC35080400020Model oceanus 35
Identity
- Trade Name
- iVascular oceanus 35 EUDAMED
- Device Name
- iVascular oceanus 35 EUDAMED
- Model / Reference
- oceanus 35 EUDAMEDBPPC35080400020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435387307657 EUDAMED
- Basic UDI-DI
- 84353873oceanus356A EUDAMED
- Direct Marketing DI
- 08435387307657 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 35 by Life Vascular Devices Biotech, S.L. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
- Advocate™ — Merit Medical Systems, Inc. · Class II
- Senri — KANEKA Corporation · Class IIa
- Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Life Vascular Devices Biotech, S.L.
- EUDAMED SRN
- ES-MF-000019783
Sources (1)
- EUDAMED b10c4250-a152-4ed4-bd8a-15eca8591db4 61 fields · synced Aug 1, 2026