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Endoscopic Image Processor
EUDAMEDFDA UDIClass I (EU MDR)
Ref HDVS-S100AModel HDVS-S100A、HDVS-S100B、HDVS-S100C、HDVS-S100D、HDVS-S100E
Identity
- Trade Name
- Endoscopic Image Processor EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Endoscopic Image Processor EUDAMEDThe product is composed of the endoscopic image processor, the foot switch, the power cord and the video cables. The foot switch and the video cables are the optional accessories. This endoscopic image processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity. FDA UDI
- Model / Reference
- HDVS-S100A、HDVS-S100B、HDVS-S100C、HDVS-S100D、HDVS-S100E EUDAMEDHDVS-S100A EUDAMEDFDA UDI
- Description
- The product is composed of the endoscopic image processor, the foot switch, the power cord and the video cables. The foot switch and the video cables are the optional accessories. This endoscopic image processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971381250473 EUDAMEDFDA UDI
- Basic UDI-DI
- 697138125009A8P EUDAMED
- 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
Endoscopic Image Processor by Scivita Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697138125009A8P | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED c0bbcb8d-1701-460a-9ae1-36fcceaf53bc 61 fields · synced Jun 20, 2026
- FDA UDI e1ea5d31-97e6-4887-ad7c-4e1a49287308 34 fields · synced May 30, 2026