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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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23.09.2026 19:09

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Diagnostic Ultrasound System

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847774
Basic UDI-DI: 69444138AcclarixLX9SEB
Reference: Acclarix LX88S
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847750
Basic UDI-DI: 69444138AcclarixLX9SEB
Reference: Acclarix LX85S
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847743
Basic UDI-DI: 69444138AcclarixLX9SEB
Reference: Acclarix LX9S Super
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847736
Basic UDI-DI: 69444138AcclarixLX9SEB
Reference: Acclarix LX9S Exp
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847729
Basic UDI-DI: 69444138AcclarixLX9SEB
Reference: Acclarix LX9S
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847668
Basic UDI-DI: 69444138AcclarixLX9SEB
Reference: Acclarix LX58S
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847644
Basic UDI-DI: 69444138AcclarixLX9SEB
Reference: Acclarix LX55S
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847637
Basic UDI-DI: 69444138AcclarixLX9SEB
Reference: Acclarix LX6S Super
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847620
Basic UDI-DI: 69444138AcclarixLX9SEB
Reference: Acclarix LX6S Exp
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847613
Basic UDI-DI: 69444138AcclarixLX9SEB
Reference: Acclarix LX6S
EMDN: Z11040101
EMDN description: INTERNAL ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Connection Cable

Connection Cable

Class IMDR 2017/745On the marketActive device

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847606
Basic UDI-DI: 69444138ConCableBK
Reference: IBP12UT01
EMDN: Z12030280
EMDN description: VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

CO-Oximeter Control Level 3

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847576
Basic UDI-DI: B-06944413847576
Reference: CO-Oximeter Control Level 3
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

CO-Oximeter Control Level 2

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847569
Basic UDI-DI: B-06944413847569
Reference: CO-Oximeter Control Level 2
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

CO-Oximeter Control Level 1

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847552
Basic UDI-DI: B-06944413847552
Reference: CO-Oximeter Control Level 1
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Gas and Electrolyte Control Level 3

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847538
Basic UDI-DI: B-06944413847538
Reference: Blood Gas and Electrolyte Control Level 3
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Gas and Electrolyte Control Level 2

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847521
Basic UDI-DI: B-06944413847521
Reference: Blood Gas and Electrolyte Control Level 2
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Gas and Electrolyte Control Level 1

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847514
Basic UDI-DI: B-06944413847514
Reference: Blood Gas and Electrolyte Control Level 1
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Calibrant Fluid Pack

i20CP300

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847507
Basic UDI-DI: B-06944413847507
Reference: i20CP300
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Calibrant Fluid Pack

i20CP200

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847491
Basic UDI-DI: B-06944413847491
Reference: i20CP200
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details

Calibrant Fluid Pack

i20CP100

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413847484
Basic UDI-DI: B-06944413847484
Reference: i20CP100
EMDN: W0101050301
EMDN description: CALIBRATORS MULTICOMPONENT (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors View details