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Stellarex 0.014" OTW Drug-coated Angioplasty Balloon
EUDAMEDClass III (EU MDR)
Ref AA14SX035080090
Identity
- Trade Name
- Stellarex 0.014" OTW Drug-coated Angioplasty Balloon EUDAMED
- Device Name
- Stellarex .014 OTW Drug-coated Angioplas EUDAMEDStellarex 0.014" OTW Drug-coated Angioplasty Balloon EUDAMED
- Model / Reference
- AA14SX035080090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813132026653 EUDAMED
- Basic UDI-DI
- B-00813132026653 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
Stellarex 0.014" 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-00813132026653 | 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 3151942c-de56-49bd-9126-a060aadcb3a3 61 fields · synced Oct 6, 2026
- EUDAMED f6b5c7fa-d736-44e3-ad25-951eaf4a9981 61 fields · synced Jul 13, 2026