Identity
- Trade Name
- CVX-300-P Excimer Laser System EUDAMEDExcimer Laser System FDA UDI
- Generic Name
- Atherectomy excimer laser system FDA UDI
- Device Name
- CVX-300-P EUDAMED
- Model / Reference
- CVX-300-P EUDAMEDFDA UDI
Identifiers
- Catalog Number
- CVX-300-P FDA UDI
- Primary DI / UDI-DI
- 00813132029937 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132029937 EUDAMED
- PMA Number
- P910001 FDA UDI
- FDA Product Code
- LPC FDA UDI
- EMDN Code
- Z12011001 EXCIMER SURGICAL LASER EUDAMED
- GMDN Term
- Atherectomy excimer laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
CVX-300-P Excimer Laser System by Spectranetics Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813132029937 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 765bbcf1-2beb-4e69-acbd-eac1967d663c 61 fields · synced Jul 17, 2026
- FDA UDI 405755ee-70e8-4ce7-8c25-828445d8e613 35 fields · synced May 30, 2026