CuRAS Hybrid
by Classys South Korea EUDAMED
Ref PQND20-ST0001Model CR2-M400 EMDN X0501
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8800016903751Y8 | Date13 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Q-Switched Nd:YAG laser system
- Model / Reference
- CR2-M400, PQND20-ST0001
- Primary DI / UDI-DI
- 08800016903751
- Basic UDI-DI
- 8800016903751Y8
- EMDN Code
- X0501 High intensity electromagnetic radiation emitting equipment without an intended medical purpose intended for use on the human body, for skin resurfacing, tattoo or hair removal or other skin treatment – laser
- Device Class
- Class IIb
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000010116
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from CLASSYS Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: 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
Sources (1)
- EUDAMED 08800016903751|8800016903751Y8