Glimessen
by Hangzhou Hikimaging Electronics Co., Ltd. China EUDAMED
Ref NAModel GET-586
EMDN Z12020401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697790480G586000000000QW | Date8 Aug 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- NIR/ICG Endoscope Camera System
- Model / Reference
- GET-586, NA
- Primary DI / UDI-DI
- 06977904801313
- Basic UDI-DI
- 697790480G586000000000QW
- EMDN Code
- Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000046099
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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 342da61c-5485-47e2-9d81-b27fdba44739