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Cellvizio® I.V.E.

Class IIaMDR 2017/745On the marketActive device

Manufacturer: MAUNA KEA TECHNOLOGIES
Manufacturer SRN: FR-MF-000000835
UDI-DI: 03760187912004
Basic UDI-DI: 376018791IVEMH
Reference: FP-10001
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: France
Authorised representative: -
Last updated: 01.08.2026 04:13

Manufacturer products View details

ECLIPSE

Surgical Camera Unit

Class IMDR 2017/745On the marketActive device

Manufacturer: Eclipse Prism Medical Devices Private Limited
Manufacturer SRN: IN-MF-000032926
UDI-DI: 08906164080884
Basic UDI-DI: 890616408SCSQW
Reference: LF90352/ Lucerna-FHD-1Chip
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Germany
Authorised representative: Mars Medical
Last updated: 01.08.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

ENVOLITE

LF90325/TCLA300

Class IMDR 2017/745On the marketActive device

Manufacturer: Eclipse Prism Medical Devices Private Limited
Manufacturer SRN: IN-MF-000032926
UDI-DI: 08906164080709
Basic UDI-DI: 890616408LSYX
Reference: LF90323/SCLA300
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Germany
Authorised representative: Mars Medical
Last updated: 01.08.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

vitra 4K1 Endoscopy Camera Head

6190

Class IMDR 2017/745On the marketActive device

Manufacturer: Cymo B.V.
Manufacturer SRN: NL-MF-000003493
UDI-DI: 08718627870396
Basic UDI-DI: 87186278700066190VF
Reference: 6190.02.02
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:47

Manufacturer products View details

vitra S Endoscopy Camera Control Unit

1180

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Cymo B.V.
Manufacturer SRN: NL-MF-000003493
UDI-DI: 08718627870273
Basic UDI-DI: 87186278700051180TW
Reference: 1180.02.01
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:47

Manufacturer products View details

7100 LED Light Source

7100

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Cymo B.V.
Manufacturer SRN: NL-MF-000003493
UDI-DI: 08718627870198
Basic UDI-DI: 87186278700047100U5
Reference: 7100.01
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:47

Manufacturer products View details

6160 HD Endoscopy Camera Control Unit

Class INot specifiedOn the marketDirect marking

Manufacturer: Cymo B.V.
Manufacturer SRN: NL-MF-000003493
UDI-DI: 08718627870235
Basic UDI-DI: 87186278700026160TS
Reference: 6160.06.01
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:44

Manufacturer products View details

1156 Endoscopy Camera Control Unit

Class INot specifiedOn the marketDirect marking

Manufacturer: Cymo B.V.
Manufacturer SRN: NL-MF-000003493
UDI-DI: 08718627870051
Basic UDI-DI: 87186278700031156TB
Reference: 1156.08.01
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:44

Manufacturer products View details

6698 HD Endoscopy Camera Control Unit

Class INot specifiedOn the marketDirect marking

Manufacturer: Cymo B.V.
Manufacturer SRN: NL-MF-000003493
UDI-DI: 08718627870037
Basic UDI-DI: 87186278700016698UZ
Reference: 6698.02.01
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Netherlands
Authorised representative: -
Last updated: 31.07.2026 23:44

Manufacturer products View details

FIBROLUX LED HP

LIGHT SOURCE

Class IMDR 2017/745On the marketActive device

Manufacturer: OPTOMIC ESPAÑA S.A
Manufacturer SRN: ES-MF-000003235
UDI-DI: 08436041580133
Basic UDI-DI: 84360415807173M
Reference: 28293114
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:49

Manufacturer products View details

06976991540273

ES80P

Class IMDR 2017/745On the marketActive deviceDirect markingReusable

Manufacturer: A-One Medical Supplies (Shenzhen) Co.,Ltd.
Manufacturer SRN: CN-MF-000048775
UDI-DI: 06976991540273
Basic UDI-DI: 697699154ES80TL
Reference: ES80P
EMDN: Z12020403
EMDN description: MODULES FOR ENDOSCOPIC IMAGING AND MINIMALLY INVASIVE SURGERY
First on market country: Spain
Authorised representative: TRANSMED GLOBAL CONSULTING, S.L.
Last updated: 31.07.2026 21:51

Manufacturer products Authorised representative products Authorised representative actors View details

Camera Control Unit

ECU-M600-A, ECU-M600-A1, ECU-M600-B,ECU-M600-B1

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Zhejiang Healnoc Technology CO., LTD
Manufacturer SRN: CN-MF-000032512
UDI-DI: 06975043221238
Basic UDI-DI: 697504322ECUM6F6
Reference: ECU-M600-A
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:43

Manufacturer products Authorised representative products Authorised representative actors View details

Electronic Endoscope Image Processor

EP 200 Pro, EP 200

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Shenzhen Zhixin Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000012801
UDI-DI: 06974525070630
Basic UDI-DI: 697452507011210103KU
Reference: EP 200 Pro
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Greece
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

06955797773719

UNP100, UNP200

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Unimicro Medical Systems (Shenzhen) Co., Ltd
Manufacturer SRN: CN-MF-000014590
UDI-DI: 06955797773719
Basic UDI-DI: 69557977UNEN001DC
Reference: UNP100
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Spain
Authorised representative: Wellkang Ltd
Last updated: 31.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

Cable

Videoscope Adaptor

Class IMDR 2017/745On the marketActive device

Manufacturer: Hangzhou Hawk Optical Electronic Instruments Co.,Ltd.
Manufacturer SRN: CN-MF-000028791
UDI-DI: 06947014617302
Basic UDI-DI: 69470146DQ00393910MR
Reference: PA41588
EMDN: Z12020499
EMDN description: INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES – OTHER
First on market country: Austria
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 20:12

Manufacturer products Authorised representative products Authorised representative actors View details

06903053047265

HB500R

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053047265
Basic UDI-DI: 69449040AB065100088F
Reference: HB500R
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: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06903053047128

UX7

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053047128
Basic UDI-DI: 69449040AB065100078D
Reference: UX3-SIM
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06903053047081

HB500

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053047081
Basic UDI-DI: 69449040AB065100098H
Reference: HB300
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: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06903053028905

LC0005S

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053028905
Basic UDI-DI: 69449040AB0651000487
Reference: LC0005L
EMDN: Z12020403
EMDN description: MODULES FOR ENDOSCOPIC IMAGING AND MINIMALLY INVASIVE SURGERY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

06937440443743

Medical Endoscope Image Processor

Class IMDR 2017/745On the marketActive deviceReusable

Manufacturer: Zhejiang YiGao Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000032913
UDI-DI: 06937440443743
Basic UDI-DI: 69368888BTV30137
Reference: BTV-300EU
EMDN: Z12020403
EMDN description: MODULES FOR ENDOSCOPIC IMAGING AND MINIMALLY INVASIVE SURGERY
First on market country: Ireland
Authorised representative: TRANSMED GLOBAL CONSULTING, S.L.
Last updated: 31.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details