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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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Test Cartridge

BG8

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413832084
Basic UDI-DI: B-06944413832084
Reference: 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 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

BG8

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413832077
Basic UDI-DI: B-06944413832077
Reference: 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 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

BG8

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413832060
Basic UDI-DI: B-06944413832060
Reference: 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 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Test Cartridge

BG8

IVD generalIVDDOn the marketMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413832053
Basic UDI-DI: B-06944413832053
Reference: 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 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Temperature Probe

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413831971
Basic UDI-DI: 69444138TPG5
Reference: TP2NS10R
EMDN: V03010201
EMDN description: TEMPERATURE MONITORING CUTANEOUS PROBES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Temperature Probe

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413831964
Basic UDI-DI: 69444138TPG5
Reference: TP2NS2R
EMDN: V03010201
EMDN description: TEMPERATURE MONITORING CUTANEOUS PROBES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Temperature Probe

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413831957
Basic UDI-DI: 69444138TPG5
Reference: TP2AS10R
EMDN: V03010201
EMDN description: TEMPERATURE MONITORING CUTANEOUS PROBES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Holter System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413831889
Basic UDI-DI: 69444138SE3012SFV
Reference: iSE-3012
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Holter System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413831834
Basic UDI-DI: 69444138SE3012SFV
Reference: SE-3012
EMDN: Z12050403
EMDN description: ECG HOLTER RECORDERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

ultrasonic transducer

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413831797
Basic UDI-DI: 69444138UTGG
Reference: C5-1XQ
EMDN: Z110402010201
EMDN description: CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Temperature Probe

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413831636
Basic UDI-DI: 69444138TPG5
Reference: TP2AS2R
EMDN: V03010201
EMDN description: TEMPERATURE MONITORING CUTANEOUS PROBES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413831612
Basic UDI-DI: 69444138NanoS8P
Reference: Nano L12
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 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413831605
Basic UDI-DI: 69444138NanoS8P
Reference: Nano C5
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 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

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