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4KINSIGHT UHD Fluorescence Imaging System

4KIR01 4KIR02 4KIR03 4KIR04 4KIR05 4KIR06 4KIR07 4KIR08 4KIR09 4KIR10 4KIR11 4KIR12

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Scivita Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010305
UDI-DI: 06971381251456
Basic UDI-DI: 697138125015A8G
Reference: 4KIR01
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:51

Manufacturer products Authorised representative products Authorised representative actors View details

Near-infrared LED Light Source

LSIR300 LSIR310 LSIR320 LSIR330

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Scivita Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010305
UDI-DI: 06971381250916
Basic UDI-DI: 697138125014A8D
Reference: LSIR300
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:51

Manufacturer products Authorised representative products Authorised representative actors View details

Endoscopic Image Processor

HDVS-S100A、HDVS-S100B、HDVS-S100C、HDVS-S100D、HDVS-S100E

Class IMDR 2017/745On the marketActive device

Manufacturer: Scivita Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010305
UDI-DI: 06971381250473
Basic UDI-DI: 697138125009A8P
Reference: HDVS-S100A
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Belgium
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:51

Manufacturer products Authorised representative products Authorised representative actors View details

LED Light Source

ES-LS100D,ES-LS110D

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Scivita Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010305
UDI-DI: 06971381250107
Basic UDI-DI: 697138125003A85
Reference: ES-LS100D
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:51

Manufacturer products Authorised representative products Authorised representative actors View details

4K UHD Camera System

ES-CS4K100/100C,ES-CS4K100/200C,ES-CS4K200/200C,ES-CS4K200/100C

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Scivita Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010305
UDI-DI: 06971381250060
Basic UDI-DI: 697138125002A82
Reference: ES-CS4K100/100C
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:51

Manufacturer products Authorised representative products Authorised representative actors View details

3D Visualization System

3DVS-S100A,3DVS-S100B,3DVS-S100C,3DVS-S100D,3DVS-S100E

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Scivita Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010305
UDI-DI: 06971381250015
Basic UDI-DI: 697138125001A7X
Reference: 3DVS-S100A
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:51

Manufacturer products Authorised representative products Authorised representative actors View details

Image Processor

MIP1001,MIP1002,MIP1003,BD-M7,MIP-B0124

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Besdata Technology Co., Ltd
Manufacturer SRN: CN-MF-000018921
UDI-DI: 06971355350628
Basic UDI-DI: 697135535064292
Reference: BD-M7
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 11:50

Manufacturer products Authorised representative products Authorised representative actors View details

06971244215083

SD-YG100A

Class IMDR 2017/745On the marketReusable

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244215083
Basic UDI-DI: 697124421CLS0001BF
Reference: SD-YG100A
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:46

Manufacturer products Authorised representative products Authorised representative actors View details

06971244215052

SD-YG500A

Class IMDR 2017/745On the marketReusable

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244215052
Basic UDI-DI: 697124421CS00084J
Reference: SD-YG500A
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:46

Manufacturer products Authorised representative products Authorised representative actors View details

06971244214994

SD-168DL

Class IMDR 2017/745On the marketReusable

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244214994
Basic UDI-DI: 697124421CL0001ZL
Reference: SD-168DL
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:46

Manufacturer products Authorised representative products Authorised representative actors View details

06971244214970

SD-4K-PA

Class IMDR 2017/745On the marketReusable

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244214970
Basic UDI-DI: 697124421CS00054C
Reference: SD-4K-PA
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:46

Manufacturer products Authorised representative products Authorised representative actors View details

06971244214963

SD-4K-3PA

Class IMDR 2017/745On the market

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244214963
Basic UDI-DI: 697124421CS00044A
Reference: SD-4K-3PA
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:46

Manufacturer products Authorised representative products Authorised representative actors View details

06971244214987

SD-LED100A

Class IMDR 2017/745On the marketReusable

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244214987
Basic UDI-DI: 697124421CLS0004BM
Reference: SD-LED100A
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:46

Manufacturer products Authorised representative products Authorised representative actors View details

06971244214956

SD-618

Class IMDR 2017/745On the marketReusable

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244214956
Basic UDI-DI: 697124421CS00064E
Reference: SD-618
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:46

Manufacturer products Authorised representative products Authorised representative actors View details

06971244214352

SD-HD668P

Class IMDR 2017/745On the marketReusable

Manufacturer: Shenyang Shenda Endoscope Co., Ltd.
Manufacturer SRN: CN-MF-000030478
UDI-DI: 06971244214352
Basic UDI-DI: 697124421CS000246
Reference: SD-HD668P
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Netherlands
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 02.07.2026 11:46

Manufacturer products Authorised representative products Authorised representative actors View details

Eview

PV220; PV300, PVX800

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000009220
UDI-DI: 06971176280135
Basic UDI-DI: 697117628EDN
Reference: PV220 (English labelling)
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Czechia
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

UE Display

UE-M10S Pro, UE-M10S Plus

Class IMDR 2017/745On the marketActive device

Manufacturer: Zhejiang UE Medical Corp.
Manufacturer SRN: CN-MF-000003020
UDI-DI: 06937048212475
Basic UDI-DI: 697028348UE000031J8
Reference: UE-M10S Pro
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 11:17

Manufacturer products Authorised representative products Authorised representative actors View details

06937048212321

VP-180, VP-180D, VP-180S, VP-180P, VP-180M

Class IMDR 2017/745On the marketActive device

Manufacturer: Zhejiang UE Medical Corp.
Manufacturer SRN: CN-MF-000003020
UDI-DI: 06937048212321
Basic UDI-DI: 697028348UE000028JK
Reference: VP-180
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 11:17

Manufacturer products Authorised representative products Authorised representative actors View details

UE Display

VPM-T35

Class IMDR 2017/745On the marketActive device

Manufacturer: Zhejiang UE Medical Corp.
Manufacturer SRN: CN-MF-000003020
UDI-DI: 06937048207617
Basic UDI-DI: 697028348UE000024JB
Reference: VPM-T35
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 11:17

Manufacturer products Authorised representative products Authorised representative actors View details

06937048205620

VS Series

Class IMDR 2017/745On the marketActive device

Manufacturer: Zhejiang UE Medical Corp.
Manufacturer SRN: CN-MF-000003020
UDI-DI: 06937048205620
Basic UDI-DI: 697028348UE000005J7
Reference: 101000014400
EMDN: Z12020480
EMDN description: INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 11:17

Manufacturer products Authorised representative products Authorised representative actors View details