Identity
- Device Name
- MonoStereo Visualization system EUDAMED
- Model / Reference
- MS-302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879963120 EUDAMED
- Basic UDI-DI
- 471987996MonoStereo2A EUDAMED
- Direct Marketing DI
- 04719879963120 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
MonoStereo Visualization system by MedicalTek 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 | 471987996MonoStereo2A | Class I | Active |
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Manufacturer
- Manufacturer
- MedicalTek Co., Ltd.
- EUDAMED SRN
- TW-MF-000014722
- Authorised Representative
- KOMAS Medical Technology GmbH DE-AR-000045617
Sources (1)
- EUDAMED 4dfe5a4a-d017-40b7-b909-ec423c09be08 61 fields · synced Jun 19, 2026