Identity
- Trade Name
- Glimessen EUDAMED
- Device Name
- NIR/ICG Endoscope Camera System EUDAMED
- Model / Reference
- GET-586 EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977904801337 EUDAMED
- Basic UDI-DI
- 697790480G586000000000QW EUDAMED
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Glimessen by Hangzhou Hikimaging Electronics Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697790480G586000000000QW | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Hikimaging Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000046099
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a8cd5aad-8ad8-4750-9744-433393701167 61 fields · synced Jun 17, 2026