Identity
- Trade Name
- Glimessen EUDAMED
- Device Name
- Medical Monitor EUDAMED
- Model / Reference
- GET-M2708SC3ALE EUDAMED354600033 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16977904805011 EUDAMED
- Basic UDI-DI
- 697790480GM2708SC3ALE0PJ EUDAMED
- EMDN Code
- Z12020499 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES – OTHER 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 | 697790480GM2708SC3ALE0PJ | 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 6d2cacca-a7d4-4eb2-8846-b8780911646c 61 fields · synced Jun 20, 2026