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3D Visualization System
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 3DVS-S100EModel 3DVS-S100A,3DVS-S100B,3DVS-S100C,3DVS-S100D,3DVS-S100E
Identity
- Trade Name
- 3D Visualization System EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- 3D Visualization System EUDAMEDThe product is composed of a host, a foot switch and HD-SDI data cables, HDMI-DVI data cables (Foot switch, HD-SDI data cables and HDMI-DVI data cables are optional). This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor. FDA UDI
- Model / Reference
- 3DVS-S100A,3DVS-S100B,3DVS-S100C,3DVS-S100D,3DVS-S100E EUDAMED3DVS-S100E EUDAMEDFDA UDI
- Description
- The product is composed of a host, a foot switch and HD-SDI data cables, HDMI-DVI data cables (Foot switch, HD-SDI data cables and HDMI-DVI data cables are optional). This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381250053 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138125001A7X EUDAMED
- Direct Marketing DI
- 06971381250053 EUDAMED
- 510(k) Number
- K183675 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
- GMDN Term
- Endoscopic video image processing unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
3D Visualization System by Scivita Medical Technology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K183675 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697138125001A7X | Class I | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED c7dac773-a034-4582-9c1a-09562e5c62dc 61 fields · synced Aug 1, 2026
- FDA UDI 54c7736b-765d-449c-9b98-6f679c99de11 35 fields · synced May 30, 2026
- FDA 510(k) K183675 1 fields · synced May 18, 2026