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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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Patient Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413810921
Basic UDI-DI: 69444138XSGP
Reference: X10
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 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

MicroSample-BG10

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413810013
Basic UDI-DI: B-06944413810013
Reference: MicroSample-BG10
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

MicroSample-BG8

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809963
Basic UDI-DI: B-06944413809963
Reference: MicroSample-BG8
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:09

Manufacturer products Authorised representative products Authorised representative actors View details

SpO2 sensor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413810846
Basic UDI-DI: 69444138SSG8
Reference: SH1
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

U60

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413810723
Basic UDI-DI: 69444138U6022
Reference: U60
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 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

MicroSample-BG10

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413810020
Basic UDI-DI: B-06944413810020
Reference: MicroSample-BG10
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

MicroSample-BG8

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809956
Basic UDI-DI: B-06944413809956
Reference: MicroSample-BG8
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

MicroSample-BG4

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809864
Basic UDI-DI: B-06944413809864
Reference: MicroSample-BG4
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:08

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

MicroSample-BG4

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809857
Basic UDI-DI: B-06944413809857
Reference: MicroSample-BG4
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

MicroSample-BG3

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809840
Basic UDI-DI: B-06944413809840
Reference: MicroSample-BG3
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

MicroSample-BG3

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809833
Basic UDI-DI: B-06944413809833
Reference: MicroSample-BG3
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

MicroSample-BC4

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809789
Basic UDI-DI: B-06944413809789
Reference: MicroSample-BC4
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

MicroSample-BC4

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809772
Basic UDI-DI: B-06944413809772
Reference: MicroSample-BC4
EMDN: W0101060605
EMDN description: BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

Connection Cable

Class IMDR 2017/745On the marketActive device

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809468
Basic UDI-DI: 69444138ConCableBK
Reference: 01.13.037477
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 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

Video Colposcope

Class IMDR 2017/745On the market

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809239
Basic UDI-DI: 69444138C3SYY
Reference: C600
EMDN: Z12020703
EMDN description: COLPOSCOPES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

Video Colposcope

Class IMDR 2017/745On the market

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809215
Basic UDI-DI: 69444138C3SYY
Reference: C300A
EMDN: Z12020703
EMDN description: COLPOSCOPES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

Video Colposcope

Class IMDR 2017/745On the market

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809208
Basic UDI-DI: 69444138C3SYY
Reference: iHC3A
EMDN: Z12020703
EMDN description: COLPOSCOPES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

Controls

Hematocrit Control High

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809123
Basic UDI-DI: B-06944413809123
Reference: Hematocrit Control High
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

Controls

Hematocrit Control Low

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809116
Basic UDI-DI: B-06944413809116
Reference: Hematocrit Control Low
EMDN: W0101050204
EMDN description: ELECTROLYTE CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:07

Manufacturer products Authorised representative products Authorised representative actors View details

Controls

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: 06944413809093
Basic UDI-DI: B-06944413809093
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 12:07

Manufacturer products Authorised representative products Authorised representative actors View details