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Stellarex 0.035" OTW Drug-coated Angioplasty Balloon
EUDAMEDClass III (EU MDR)
Ref A35SX040200080
Identity
- Trade Name
- Stellarex 0.035" OTW Drug-coated Angioplasty Balloon EUDAMED
- Device Name
- Stellarex .035 OTW Drug-coated Angioplas EUDAMEDStellarex 0.035" OTW Drug-coated Angioplasty Balloon EUDAMED
- Model / Reference
- A35SX040200080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813132027001 EUDAMED
- Basic UDI-DI
- B-00813132027001 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Category: Peripheral angioplasty balloon catheter, basic
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon by Spectranetics Corporation — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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- 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813132027001 | Class III | Active |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (2)
- EUDAMED ff7e4638-9b59-4f75-988f-c00fb87b1fbe 61 fields · synced Oct 6, 2026
- EUDAMED 94de52c6-99a3-4244-96e9-563d38650ba4 61 fields · synced Aug 1, 2026