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Full HD Endoscopic Image Processor
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref HDVS-S200BModel HDVS-S200A 、HDVS-S200B 、HDVS-S200C、 HDVS-S200D510(k) K240289
Identity
- Trade Name
- Full HD Endoscopic Image Processor EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Full HD Endoscopic Image Processor EUDAMEDThis product is composed of the Full HD Endoscopic Image Processor, the foot switch, the power cable and video cable. Video cable includes SDI video cable and DVI video cable. The foot switch is optional. This product is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging. FDA UDI
- Model / Reference
- HDVS-S200A 、HDVS-S200B 、HDVS-S200C、 HDVS-S200D EUDAMEDHDVS-S200B EUDAMEDFDA UDI
- Description
- This product is composed of the Full HD Endoscopic Image Processor, the foot switch, the power cable and video cable. Video cable includes SDI video cable and DVI video cable. The foot switch is optional. This product is used in combination with Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) to process the image collected by the electronic endoscope and transfer them to the monitor for imaging. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381252545 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138125025A8M EUDAMED
- 510(k) Number
- K240289 FDA UDI
- FDA Product Code
- EOQ 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
- 874.4680 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Full HD Endoscopic Image Processor 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 | K240289 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697138125025A8M | 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 1cb4ef96-e46e-4e51-a45c-aa25246ea2ad 85 fields · synced Jun 19, 2026
- FDA UDI 69dfd670-ca8f-48a4-927a-6eaff2f087c3 34 fields · synced May 30, 2026
- FDA 510(k) K240289 1 fields · synced May 18, 2026