Identity
- Trade Name
- Turbo-Power Laser atherectomy catheter EUDAMED
- Device Name
- Turbo-Power Laser Atherectomy Catheter EUDAMED
- Model / Reference
- 420-050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813132029258 EUDAMED
- Basic UDI-DI
- 081313202BM389MP EUDAMED
- EMDN Code
- C010402020602 PERIPHERAL ATHERECTOMY SYSTEMS, ROTATIONAL EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Turbo-Power Laser atherectomy catheter by Philips Image Guided Therapy Corporation — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 081313202BM389MP | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Image Guided Therapy Corporation
- EUDAMED SRN
- US-MF-000018632
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (1)
- EUDAMED 612b2024-29b4-46bd-b029-53daa7016830 61 fields · synced Jul 15, 2026