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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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08.07.2026 23:18

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Calibrant Fluid Pack

i20CP200

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413815223
Basic UDI-DI: B-06944413815223
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 12:14

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: 06944413815216
Basic UDI-DI: B-06944413815216
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 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Calibrant Fuild Pack

i20CP100

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413815209
Basic UDI-DI: B-06944413815209
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 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Calibrant Fluid Pack

i20CP50

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413815193
Basic UDI-DI: B-06944413815193
Reference: i20CP50
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 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Calibrant Fluid Pack

i20CP50

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413815186
Basic UDI-DI: B-06944413815186
Reference: i20CP50
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 12:14

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: 06944413815032
Basic UDI-DI: 69444138ConCableBK
Reference: 01.57.472179
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 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Trolley (for medical use)

Trolley (for medical use)

Class IMDR 2017/745On the market

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814714
Basic UDI-DI: 69444138Trolley503SMX
Reference: MT-503(S)
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 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Trolley (for medical use)

Trolley (for medical use)

Class IMDR 2017/745On the market

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814707
Basic UDI-DI: 69444138Trolley503SMX
Reference: MT-503N
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 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Trolley (for medical use)

Trolley (for medical use)

Class IMDR 2017/745On the market

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814691
Basic UDI-DI: 69444138Trolley503SMX
Reference: MT-503
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 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Gas and Chemistry Analyzer

i2005

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814424
Basic UDI-DI: B-06944413814424
Reference: i2005
EMDN: W0201040102
EMDN description: BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

HL310

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814417
Basic UDI-DI: 69444138HL310KD
Reference: HL310
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

HL310

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814400
Basic UDI-DI: 69444138HL310KD
Reference: HL310
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Gas and Chemistry Analyzer

i20

IVD generalIVDDOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814394
Basic UDI-DI: B-06944413814394
Reference: i20
EMDN: W0201040102
EMDN description: BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

ECG cable

Class IMDR 2017/745On the marketActive device

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814370
Basic UDI-DI: 69444138ECGCableOWG
Reference: FECG-3ISL
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 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

ECG cable

Class IMDR 2017/745On the marketActive device

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814363
Basic UDI-DI: 69444138ECGCableOWG
Reference: FECG-3ISU
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 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

FECG1

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814318
Basic UDI-DI: 69444138FECG1MJ
Reference: FECG1
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

ECG Analysis Software

ECG Analysis Software

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814301
Basic UDI-DI: 69444138AISEMIPV3
Reference: AI-SEMIP
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

ECG Analysis Software

ECG Analysis Software

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814295
Basic UDI-DI: 69444138AISEMIPV3
Reference: SE-1818
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

ECG Analysis Software

ECG Analysis Software

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814288
Basic UDI-DI: 69444138AISEMIPV3
Reference: Intelligent ECG Platform
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

ECG Analysis Software

ECG Analysis Software

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814271
Basic UDI-DI: 69444138AISEMIPV3
Reference: smart ECG Net
EMDN: Z12059009
EMDN description: ECG DATA MANAGEMENT SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details