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MonoStereo Visualization system
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref MS-301Ref MS-3D02
Identity
- Device Name
- MonoStereo Visualization system EUDAMED
- Model / Reference
- MS-301 EUDAMEDMS-3D02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719879963014 EUDAMED04719879963021 EUDAMED
- Basic UDI-DI
- 471987996MonoStereo2A EUDAMED
- Direct Marketing DI
- 04719879963014 EUDAMED04719879963021 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K234096 | Class I | Active |
| 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 (3)
- EUDAMED 6f7f6a04-b82a-4dc5-813c-be6b21191777 61 fields · synced Jul 24, 2026
- EUDAMED 1aa8988f-677f-4661-a097-811a8d98cd9f 61 fields · synced May 18, 2026
- FDA 510(k) K234096 1 fields · synced May 18, 2026