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Stellarex 0.035" OTW Drug-coated Angioplasty Balloon
EUDAMEDClass III (EU MDR)
Ref A35SX050080080
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
- A35SX050080080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813132026233 EUDAMED
- Basic UDI-DI
- B-00813132026233 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
No
EUDAMEDEUDAMED
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon by Spectranetics Corporation — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-00813132026233 | 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 88b08955-513c-416e-9ad1-ba600f6a90fb 61 fields · synced Jun 19, 2026
- EUDAMED 9a981380-8972-44aa-b307-4f0b8aa345a3 61 fields · synced Jun 14, 2026