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Endoscope Illuminator

Endoscope Illuminator, Light Guide Bundles

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shenzhen Edge Medical Co., Ltd.
Manufacturer SRN: CN-MF-000039045
UDI-DI: 06975070992989
Basic UDI-DI: 697507099EI000ES
Reference: HE1003
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 18:04

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Fiber Optic Light Cable

LC-3530-F；LC-4830-F；LC-4850-F

Class IMDR 2017/745On the market

Manufacturer: Zhejiang Healnoc Technology CO., LTD
Manufacturer SRN: CN-MF-000032512
UDI-DI: 06975043223232
Basic UDI-DI: 697504322LCI353B3
Reference: LC-3530-F；LC-4830-F；LC-4850-F
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 17:56

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06975043221276

ECH-F500

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Zhejiang Healnoc Technology CO., LTD
Manufacturer SRN: CN-MF-000032512
UDI-DI: 06975043221276
Basic UDI-DI: 697504322ECHF5CE
Reference: ECH-F500
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:56

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Camera Control Unit

ECU-C410-A

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Zhejiang Healnoc Technology CO., LTD
Manufacturer SRN: CN-MF-000032512
UDI-DI: 06975043220972
Basic UDI-DI: 697504322ECUC4E4
Reference: CN-MF-000032512
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:56

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Endoscopic Cold Light Source

ELL-200M

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Zhejiang Healnoc Technology CO., LTD
Manufacturer SRN: CN-MF-000032512
UDI-DI: 06975043220507
Basic UDI-DI: 697504322ELL4KEQ
Reference: ELL-200M
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 17:56

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Istruzioni per l'Uso Sistema di elaborazione delle immagini 4K NIR/ICG Sistema con telecamera endosco

ECS-F400

Class IMDR 2017/745On the marketActive device

Manufacturer: Zhejiang Healnoc Technology CO., LTD
Manufacturer SRN: CN-MF-000032512
UDI-DI: 06975043220835
Basic UDI-DI: 697504322ECS4KDU
Reference: CN-MF-000032512
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:56

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06975043221177

ECH-301

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Zhejiang Healnoc Technology CO., LTD
Manufacturer SRN: CN-MF-000032512
UDI-DI: 06975043221177
Basic UDI-DI: 697504322ECH50AL
Reference: ECH-301-P
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:56

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Endoscopic Camera System

ECS-400; ECS-400A; ECS-400B; ECS-400C; ECS-401; ECS-410; ECS-400D

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Zhejiang Healnoc Technology CO., LTD
Manufacturer SRN: CN-MF-000032512
UDI-DI: 06975043220286
Basic UDI-DI: 697504322ECS00BU
Reference: ECS-400; ECS-400A; ECS-400B; ECS-400C; ECS-401; ECS-410; ECS-400D
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 17:55

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Endoscopic LED Cold Light Source

ELL-080A; ELL-080B; ELL-080C

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Zhejiang Healnoc Technology CO., LTD
Manufacturer SRN: CN-MF-000032512
UDI-DI: 06975043220279
Basic UDI-DI: 697504322ELL00CQ
Reference: ELL-080A; ELL-080B; ELL-080C
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Germany
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 17:55

Manufacturer products Authorised representative products Authorised representative actors View details

HTx image processing system

HTx1000, HTx2000

Class IMDR 2017/745On the marketActive device

Manufacturer: Suzhou AcuVu Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000038586
UDI-DI: 06974880991304
Basic UDI-DI: 697488099IPS002XF
Reference: /
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Ireland
Authorised representative: Eunitor GmbH
Last updated: 02.07.2026 17:38

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Sentire Surgical System

CV2001

Class IIaMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: Cornerstone Technology (Shenzhen) Limited
Manufacturer SRN: CN-MF-000046027
UDI-DI: 06974771910650
Basic UDI-DI: 697477191BS0002GS
Reference: CV2001
EMDN: Z12020403
EMDN description: MODULES FOR ENDOSCOPIC IMAGING AND MINIMALLY INVASIVE SURGERY
First on market country: Germany
Authorised representative: Cornerstone Robotics B.V.
Last updated: 02.07.2026 17:27

Manufacturer products Authorised representative products Authorised representative actors View details

06974710259468

EPU-500

Class IMDR 2017/745On the marketActive device

Manufacturer: Miconvey Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000031532
UDI-DI: 06974710259468
Basic UDI-DI: 697471025EPU-MDR-CKM
Reference: EPU-500
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

06974626430050

X1-B, X1-BI, X1-BII, X1-BIII, X1-BIV, X1-BV

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Proxinse Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000008916
UDI-DI: 06974626430050
Basic UDI-DI: 6974626430050BE
Reference: none
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 02.07.2026 17:05

Manufacturer products Authorised representative products Authorised representative actors View details

06974626430005

PX-800, PX-850

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Proxinse Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000008916
UDI-DI: 06974626430005
Basic UDI-DI: 6974626430005B9
Reference: PX-800, PX-850
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 02.07.2026 17:05

Manufacturer products Authorised representative products Authorised representative actors View details

EASYVISTAR

ENT05

Class IMDR 2017/745On the marketActive deviceDirect markingReusableSterile

Manufacturer: Shantou Easywell Electronic Technologies Co.,Ltd.
Manufacturer SRN: CN-MF-000016725
UDI-DI: 06974471531704
Basic UDI-DI: 697447153ENTU5
Reference: ENT05
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

EASYVISTAR

EM32-4KA

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shantou Easywell Electronic Technologies Co.,Ltd.
Manufacturer SRN: CN-MF-000016725
UDI-DI: 06974471531698
Basic UDI-DI: 697447153169MD
Reference: EM32-4KA
EMDN: Z12020480
EMDN description: INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES
First on market country: Greece
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:14

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EASYVISTAR

KS-ELS200A

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shantou Easywell Electronic Technologies Co.,Ltd.
Manufacturer SRN: CN-MF-000016725
UDI-DI: 06974471531643
Basic UDI-DI: 697447153164M3
Reference: KS-ELS200A
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Greece
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

EASYVISTAR

KS-ELS100A

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shantou Easywell Electronic Technologies Co.,Ltd.
Manufacturer SRN: CN-MF-000016725
UDI-DI: 06974471531636
Basic UDI-DI: 697447153163LZ
Reference: KS-ELAS100A
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Hungary
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

EASYVISTAR

E10U

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shantou Easywell Electronic Technologies Co.,Ltd.
Manufacturer SRN: CN-MF-000016725
UDI-DI: 06974471531605
Basic UDI-DI: 697447153160LT
Reference: E10U
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Romania
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details

EASYVISTAR

E42B

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shantou Easywell Electronic Technologies Co.,Ltd.
Manufacturer SRN: CN-MF-000016725
UDI-DI: 06974471531568
Basic UDI-DI: 697447153156M4
Reference: E42B
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Hungary
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:14

Manufacturer products Authorised representative products Authorised representative actors View details