Laser Positioning System
by Klarity Medical & Equipment（GZ） Co., Ltd. EUDAMED
Active
Ref K-ARL-M3Model Many
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number692082412652DK | Date1 Aug 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Laser Positioning System
- Model / Reference
- Many, K-ARL-M3
- Primary DI / UDI-DI
- 06920824126523
- Basic UDI-DI
- 692082412652DK
- EMDN Code
- Z119010 Laser systems for patient positioning
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000002229
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Klarity Medical & Equipment（GZ） Co., Ltd.
See all devices from Klarity Medical & Equipment（GZ） Co., Ltd. →
Properties
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