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CAS-One IR Pointer A

CAS-One IR Pointer

Class IMDR 2017/745On the marketDirect marking

Manufacturer: CASCINATION AG
Manufacturer SRN: CH-MF-000009927
UDI-DI: 07616962000120
Basic UDI-DI: 764016722122C1R001L5
Reference: 30027
EMDN: Z12011480
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: CAScination Deutschland GmbH
Last updated: 03.07.2026 06:28

Manufacturer products Authorised representative products Authorised representative actors View details

CAS-One IR Software

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: CASCINATION AG
Manufacturer SRN: CH-MF-000009927
UDI-DI: 07616962000090
Basic UDI-DI: 764016722300C1R001KB
Reference: 20016
EMDN: Z12011492
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: CAScination Deutschland GmbH
Last updated: 03.07.2026 06:28

Manufacturer products Authorised representative products Authorised representative actors View details

Navident EVO cart

955-ND-ND

Class IIaMDR 2017/745On the marketActive device

Manufacturer: ClaroNav Inc.
Manufacturer SRN: CA-MF-000028837
UDI-DI: 07540209956478
Basic UDI-DI: 7540209955-ND-NDUL
Reference: 955-ND-ND-201
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

Navient Air

Class IMDR 2017/745On the marketActive device

Manufacturer: Claronav Kolahi
Manufacturer SRN: CA-MF-000037841
UDI-DI: 07540209956386
Basic UDI-DI: 7540209955-NC-NAVIAIR2F
Reference: 950-NC-AIR
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: Greece
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

Universal Tracker for Biopsy

Disposable Instruments

Class IMDR 2017/745On the marketSingle use

Manufacturer: Claronav Kolahi
Manufacturer SRN: CA-MF-000037841
UDI-DI: 07540209955723
Basic UDI-DI: 7540209955-NC-DINSTQM
Reference: 950-NC-UTB
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Greece
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

Navient ENT Accessory Kit

Navient Instruments

Class IMDR 2017/745On the market

Manufacturer: Claronav Kolahi
Manufacturer SRN: CA-MF-000037841
UDI-DI: 07540209955105
Basic UDI-DI: 7540209955-NC-REUSDA
Reference: 955-NE-ACCK
EMDN: Z12011480
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

Navident Accessory Kit

Class IMDR 2017/745On the market

Manufacturer: ClaroNav Inc.
Manufacturer SRN: CA-MF-000028837
UDI-DI: 07540209955037
Basic UDI-DI: 7540209955-ND-KITSCP
Reference: 955-ND-ACCK
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 05:26

Manufacturer products Authorised representative products Authorised representative actors View details

OTS™ Medizinisches elektrisches System

OTS Medical Electrical System

Class IMDR 2017/745On the marketActive device

Manufacturer: Ortoma AB
Manufacturer SRN: SE-MF-000034945
UDI-DI: 07350137520890
Basic UDI-DI: 735013752OTSMESHC
Reference: 30-226
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:05

Manufacturer products View details

OTS™ Tracer IN

OTS Tracers

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: Ortoma AB
Manufacturer SRN: SE-MF-000034945
UDI-DI: 07350137520111
Basic UDI-DI: 735013752OTSTracersSP
Reference: 30-151
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:05

Manufacturer products View details

OTS™ Hüftführungssystem

OTS Hip Guide

Class IIbMDR 2017/745On the market

Manufacturer: Ortoma AB
Manufacturer SRN: SE-PR-000048670
UDI-DI: 07350137520012
Basic UDI-DI: 735013752OTSHipLY
Reference: 30-101
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: -
Authorised representative: -
Last updated: 03.07.2026 05:05

Manufacturer products View details

OTS™ Mandrin und Pin

OTS Reusable Instruments

Class IMDR 2017/745On the marketCMR substanceDirect markingReusable

Manufacturer: Ortoma AB
Manufacturer SRN: SE-MF-000034945
UDI-DI: 07350137520036
Basic UDI-DI: 735013752OTSInstrument39
Reference: 30-117
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:05

Manufacturer products View details

OTS™ Hüftführungs-Software

OTS Hip Guide Software

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Ortoma AB
Manufacturer SRN: SE-MF-000034945
UDI-DI: 07350137520029
Basic UDI-DI: 735013752OTSHipGuideQN
Reference: 20-100
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:05

Manufacturer products View details

IGI

AIG0005-V2

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Image Navigation
Manufacturer SRN: IL-MF-000033689
UDI-DI: 07290016855104
Basic UDI-DI: 7290016855AIG0005ZS
Reference: AIG0005-V2
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

AimMarker

AM-BL130

Class IMDR 2017/745On the marketSingle use

Manufacturer: Guangzhou Aimooe Technology Co., Ltd.
Manufacturer SRN: CN-MF-000039729
UDI-DI: 06976077050085
Basic UDI-DI: 6976077053010-0201ND
Reference: 3005
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Belgium
Authorised representative: Share info GmbH
Last updated: 02.07.2026 20:40

Manufacturer products Authorised representative products Authorised representative actors View details

Dental Implant Navigation Equipment

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Suzhou Digital-health Care Co. Ltd.
Manufacturer SRN: CN-MF-000035238
UDI-DI: 06975155840280
Basic UDI-DI: 697515584001LW
Reference: DHC-DI7
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

Yakebot

DRS-02-RA-Pro

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Beijing Yakebot Technology Co., Ltd.
Manufacturer SRN: CN-MF-000038958
UDI-DI: 06975130760084
Basic UDI-DI: 697513076008JC
Reference: CYK000000013
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: Germany
Authorised representative: PureCE B.V.
Last updated: 02.07.2026 18:14

Manufacturer products Authorised representative products Authorised representative actors View details

06975102670113

EMNC001

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Changzhou Lunghealth Medtech Co,. Ltd.
Manufacturer SRN: CN-MF-000024014
UDI-DI: 06975102670113
Basic UDI-DI: 6975102676975102670113VU
Reference: EMNC001-T17A
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Romania
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

06975102670083

EMND001

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Changzhou Lunghealth Medtech Co,. Ltd.
Manufacturer SRN: CN-MF-000024014
UDI-DI: 06975102670083
Basic UDI-DI: 6975102676975102670083WC
Reference: EMND001A
EMDN: Z12011480
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Romania
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

06975102670007

EMNC002

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Changzhou Lunghealth Medtech Co,. Ltd.
Manufacturer SRN: CN-MF-000024014
UDI-DI: 06975102670007
Basic UDI-DI: 6975102676975102670137WA
Reference: EMNC002-G26OP00
EMDN: Z12011485
EMDN description: SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES
First on market country: Romania
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

06974385360025

XGK-6508B

Class IIbMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Shenzhen Futurtec Medical Co.，LTD.
Manufacturer SRN: CN-MF-000034856
UDI-DI: 06974385360025
Basic UDI-DI: 697438536XGK-6508BK3
Reference: XGK-6508B
EMDN: Z12011401
EMDN description: SURGICAL NAVIGATION SYSTEM
First on market country: Northern Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:56

Manufacturer products Authorised representative products Authorised representative actors View details