Velure S5
by Lasering s.r.l. Italy EUDAMEDGUDID
Ref AT0230Model VELURE
Product code GEXEMDN Z12011006
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number805647709VELURESR | Date30 Aug 2023 | StatusActive |
| United States | GUDID listing GUDID | Number08056477090022 | Date7 Jun 2018 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Velure S5 EUDAMEDLasering SRL GUDID
- Generic Name
- Dermatological solid-state laser system
- Device Name
- Velure
- Model / Reference
- VELURE EUDAMEDAT0230 EUDAMEDVELURE S5 GUDID
- Primary DI / UDI-DI
- 08056477090022
- Basic UDI-DI
- 805647709VELURESR
- Direct Marketing DI
- 08056477090022
- FDA Product Code
- GEX
- EMDN Code
- Z12011006 Diode–pumped solid–state (dpss) surgical laser
- GMDN Term
- Dermatological solid-state laser system
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 878.4810
- Market of Registration
- Italy
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | VELURE AT0230 | VELURE S5 |
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- IT-MF-000020505
Other devices from Lasering s.r.l.
Properties & raw data
Show properties, registry sources and raw records
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
Sources (2)
- EUDAMED 8a6db611-e8b4-45bf-96cc-99025fcffdcb
- FDA UDI fd8fbe4b-706f-41b4-a9c6-c457feaa2ee2