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Turbo-Elite Laser Atherectomy Catheter
EUDAMEDClass IIa (EU MDR)
Ref 425-135-02
Identity
- Trade Name
- Turbo-Elite Laser Atherectomy Catheter EUDAMED
- Device Name
- Turbo-Elite Laser Atherectomy Catheter EUDAMED
- Model / Reference
- 425-135-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813132024826 EUDAMED
- Basic UDI-DI
- B-00813132024826 EUDAMED
- EMDN Code
- C010402020699 PERIPHERAL ATHERECTOMY SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Turbo-Elite Laser Atherectomy Catheter by Spectranetics Corporation — Class IIa — 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-00813132024826 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (1)
- EUDAMED e609d183-166c-4055-b390-7b54e95f02d2 61 fields · synced May 23, 2026