Identity
- Trade Name
- Glimessen EUDAMED
- Device Name
- Medical Endoscope Camera System EUDAMED
- Model / Reference
- GET-321X EUDAMED354300432 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977904800217 EUDAMED
- Basic UDI-DI
- 697790480G321X000000008D 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
- Germany 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 | 697790480G321X000000008D | 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 166d7193-0b00-444c-8158-ee9ada5d2449 61 fields · synced Jun 19, 2026