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10886705028702

Camera Control System

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Medos International SARL
Manufacturer SRN: CH-MF-000014268
UDI-DI: 10886705028702
Basic UDI-DI: 0886705a00008K7
Reference: 242302
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Belgium
Authorised representative: DePuy Ireland UC
Last updated: 16.07.2026 07:36

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Endoscope with Light source

Wireless-CAM

Class IMDR 2017/745On the marketActive device

Manufacturer: M.I.ONE Co., Ltd.
Manufacturer SRN: KR-MF-000050358
UDI-DI: 08800138500319
Basic UDI-DI: 08800138CW-2000UY
Reference: LED-Z1270
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Belgium
Authorised representative: AF Pharma Service Europe SL
Last updated: 16.07.2026 07:05

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Light source

Endoscope Camera System

Class IMDR 2017/745On the marketActive device

Manufacturer: M.I.ONE Co., Ltd.
Manufacturer SRN: KR-MF-000050358
UDI-DI: 08800138500081
Basic UDI-DI: 08800138CCU-2200XW
Reference: LED-150C
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Belgium
Authorised representative: AF Pharma Service Europe SL
Last updated: 16.07.2026 07:05

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Unity 9000 Digital Video Processor

UNITY-9000

Class IMDR 2017/745On the marketActive device

Manufacturer: Cogentix Medical, Inc.
Manufacturer SRN: US-MF-000041661
UDI-DI: 00874485003494
Basic UDI-DI: 087448500UNITYKG
Reference: 07-9000
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Netherlands
Authorised representative: Medical Measurement Systems B.V.
Last updated: 16.07.2026 07:01

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BLS-1000 Battery Light Source Replacement

07-3050

Class IMDR 2017/745On the marketActive device

Manufacturer: Cogentix Medical, Inc.
Manufacturer SRN: US-MF-000041661
UDI-DI: 00874485000318
Basic UDI-DI: 087448500BLS10008K
Reference: 07-3050
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Netherlands
Authorised representative: Medical Measurement Systems B.V.
Last updated: 16.07.2026 07:01

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VoirElite 4K 31.5"

Fiber & SD: JMASM00077; SDVoE & SDI: JMASM00081; HDMI & SDI: JMASM00082

Class IMDR 2017/745On the marketDirect marking

Manufacturer: JAM-Labs Corp.
Manufacturer SRN: US-MF-000038257
UDI-DI: 00860008848925
Basic UDI-DI: 08600088489JMASM000773B
Reference: Fiber & SDI (JMASM00077)___ SDVoE & SDI (JMASM00081)___ HDMI & SDI (JMASM00082)
EMDN: Z12020499
EMDN description: INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES – OTHER
First on market country: Ireland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:52

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ORION RACK Assembly

JMKIT00004

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: JAM-Labs Corp.
Manufacturer SRN: US-MF-000038257
UDI-DI: 00860008848901
Basic UDI-DI: 08600088489JMASM000893J
Reference: JMKIT00004
EMDN: Z12020401
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Ireland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:52

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Pharos HD

P003500

Class IMDR 2017/745On the marketActive device

Manufacturer: Long Island Technology Group, LLC
Manufacturer SRN: US-MF-000014025
UDI-DI: 00851610007374
Basic UDI-DI: 0851610007P003500AA
Reference: BFW 8010A, BFW 8010B, BFW 8010 H/L, BFW 8010 CCU
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:34

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Hatteras

P002700

Class IMDR 2017/745On the marketActive device

Manufacturer: Long Island Technology Group, LLC
Manufacturer SRN: US-MF-000014025
UDI-DI: 00851610007107
Basic UDI-DI: 0851610007P002700AD
Reference: BFW 1600B, BFW 1600S
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Germany
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:34

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UroViu 4500 Imaging Handle

4500EU

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: UroViu Corporation
Manufacturer SRN: US-MF-000039864
UDI-DI: 00850051518135
Basic UDI-DI: 08500515184500EU5H
Reference: 4500EU
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: France
Authorised representative: Casus Europe B.V.
Last updated: 16.07.2026 06:30

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BLS-1000 Light Source Kit, Europe

Class IMDR 2017/745On the marketActive device

Manufacturer: Cogentix Medical, Inc.
Manufacturer SRN: US-MF-000041661
UDI-DI: 00874485002084
Basic UDI-DI: 087448500BLS10008K
Reference: 07-3053-EU
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: -
Authorised representative: Medical Measurement Systems B.V.
Last updated: 16.07.2026 06:27

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Aptra

OTU-A, OTU-T, OTU-A Pro, OTU-T Pro, BDVP01

Class IMDR 2017/745On the marketActive device

Manufacturer: OTU MEDICAL INC.
Manufacturer SRN: US-MF-000020690
UDI-DI: 00850023925015
Basic UDI-DI: 0850023925003RH
Reference: BDVP01
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Belgium
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 06:20

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CONMED

Non-orthopedic, Active, Video Diagnosing/Monitoring, Camera head

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Conmed Corporation
Manufacturer SRN: US-MF-000012663
UDI-DI: 10845854044360
Basic UDI-DI: 084585408544DH
Reference: IM8124
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Belgium
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:05

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Zeos

Light Guide and Adapter

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: Santa Barbara Imaging Systems, Inc.
Manufacturer SRN: US-MF-000007262
UDI-DI: 00853460007153
Basic UDI-DI: 0812231038X-20-XXXXXF
Reference: 84-20-5004
EMDN: Z12020480
EMDN description: INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - HARDWARE ACCESSORIES
First on market country: Netherlands
Authorised representative: Qualrep Services B.V.
Last updated: 16.07.2026 04:13

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Pixa

4K HDR Camera System

Class IMDR 2017/745On the marketActive device

Manufacturer: Santa Barbara Imaging Systems, Inc.
Manufacturer SRN: US-MF-000007262
UDI-DI: 00812231033821
Basic UDI-DI: 0812231038X-10-XXXXWW
Reference: 85-10-5001
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: Qualrep Services B.V.
Last updated: 16.07.2026 04:11

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SPOTLIGHT ACCESS SYSTEM

Spotlight Port Instruments

Class IIaMDR 2017/745On the marketCMR substanceDirect markingReusable

Manufacturer: Medos International SARL
Manufacturer SRN: CH-MF-000014268
UDI-DI: 10705034205496
Basic UDI-DI: 0705034a002145R
Reference: 282912030
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Belgium
Authorised representative: DePuy Ireland UC
Last updated: 16.07.2026 02:45

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PIPELINE ACCESS SYSTEM

Pipeline Access System Reusable Instruments Light source for minimally invasive surgery

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: Medos International SARL
Manufacturer SRN: CH-MF-000014268
UDI-DI: 10705034220727
Basic UDI-DI: 0705034a001415P
Reference: 288210015
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Belgium
Authorised representative: DePuy Ireland UC
Last updated: 16.07.2026 02:34

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EXALT™

EXALT Controller

Class IMDR 2017/745On the marketActive device

Manufacturer: Boston Scientific Corporation
Manufacturer SRN: US-MF-000004702
UDI-DI: 08714729990901
Basic UDI-DI: 01915060000000000000067MY
Reference: M00542430
EMDN: Z12020406
EMDN description: VIDEO PROCESSORS
First on market country: Netherlands
Authorised representative: Boston Scientific Limited
Last updated: 15.07.2026 22:59

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04049047657545

Class INot specifiedOn the marketDirect markingSingle use

Manufacturer: Gimmi GmbH
Manufacturer SRN: DE-MF-000005445
UDI-DI: 04049047657545
Basic UDI-DI: 4049047ZAD15AAA27DREP7
Reference: E.8230.48 LED
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:56

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04049047657569

Class INot specifiedOn the marketDirect markingSingle use

Manufacturer: Gimmi GmbH
Manufacturer SRN: DE-MF-000005445
UDI-DI: 04049047657569
Basic UDI-DI: 4049047ZAD15AAA27DREP7
Reference: E.8300.48 LED
EMDN: Z12020402
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: -
Authorised representative: -
Last updated: 15.07.2026 22:56

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