Bowin
by Bowin Medical Co., Ltd EUDAMED
Active
Ref LEDTECH5000MModel LEDTECH7575、LEDTECH7050、LEDTECH7070、LEDTECH5050、LEDTECH7550、LEDTECH3030、LEDTECH7500、LEDTECH7000、LEDTECH5000、LEDTECH3000、LEDTECH7000W、LEDTECH5000W、LEDTECH3000W、LEDTECH7500M、LEDTECH7000M、LEDTECH5000M、 LEDTECH3000M、
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697460673LEDSLS001UG | Date30 Jan 2024 | 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- Withdrawn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
- LED Surgical Lighting System
- Model / Reference
- LEDTECH7575、LEDTECH7050、LEDTECH7070、LEDTECH5050、LEDTECH7550、LEDTECH3030、LEDTECH7500、LEDTECH7000、LEDTECH5000、LEDTECH3000、LEDTECH7000W、LEDTECH5000W、LEDTECH3000W、LEDTECH7500M、LEDTECH7000M、LEDTECH5000M、 LEDTECH3000M、, LEDTECH5000M
- Primary DI / UDI-DI
- 06974606730156
- Basic UDI-DI
- 697460673LEDSLS001UG
- EMDN Code
- Z12010701,Z12010702
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000022780
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Bowin Medical Co., Ltd
Properties
Other properties (12)
- Sterile: No
- Implantable: 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