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Biofeedback and Stimulation System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413812406
Basic UDI-DI: 69444138PSFX
Reference: PE16
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

Biofeedback and Stimulation System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413812345
Basic UDI-DI: 69444138PSFX
Reference: P36
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

Electrocardiograph

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413812246
Basic UDI-DI: 69444138iSES3X
Reference: iSE-1810
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:11

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: 06944413812192
Basic UDI-DI: 69444138UTGG
Reference: C6-2MQ
EMDN: Z110402010202
EMDN description: CURVILINEAR TRANSCUTANEOUS MULTIDIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

Electrocardiograph

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413812239
Basic UDI-DI: 69444138iSES3X
Reference: iSE-1210
EMDN: Z12050301
EMDN description: GENERAL PURPOSE ELECTROCARDIOGRAPHS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:11

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: 06944413812208
Basic UDI-DI: 69444138UTGG
Reference: C5-1Q
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 12:11

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: 06944413812185
Basic UDI-DI: 69444138UTGG
Reference: L17-7Q
EMDN: Z110402010101
EMDN description: TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

ultrasonic transducer

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413812161
Basic UDI-DI: 69444138UTGG
Reference: E10-3BQ
EMDN: Z1104020201
EMDN description: ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

ultrasonic transducer

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413812154
Basic UDI-DI: 69444138UTGG
Reference: E10-3HQ
EMDN: Z1104020201
EMDN description: ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:11

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: 06944413812147
Basic UDI-DI: 69444138UTGG
Reference: C7-2XQ
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 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

NIBP Tube

Class IMDR 2017/745On the marketActive device

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413812109
Basic UDI-DI: 69444138NIBPTubeMD
Reference: 01.57.472010
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 12:11

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: 06944413812055
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 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

NIBP Tube

Class IMDR 2017/745On the marketActive device

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413812048
Basic UDI-DI: 69444138NIBPTubeMD
Reference: BPT3
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 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal & Maternal Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413811973
Basic UDI-DI: 69444138F15SNQ
Reference: F15 Air
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 12:11

Manufacturer products Authorised representative products Authorised representative actors View details

Fetal & Maternal Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413811966
Basic UDI-DI: 69444138F15SNQ
Reference: F15
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 12:10

Manufacturer products Authorised representative products Authorised representative actors View details

Biofeedback and Stimulation System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413811942
Basic UDI-DI: 69444138PSFX
Reference: PE2
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors View details

Biofeedback and Stimulation System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413811935
Basic UDI-DI: 69444138PSFX
Reference: P2
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors View details

Biofeedback and Stimulation System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413811928
Basic UDI-DI: 69444138PSFX
Reference: P4
EMDN: U070399
EMDN description: PELVIC FLOOR REHABILITATION DEVICES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:10

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: 06944413811911
Basic UDI-DI: 69444138ECGCableEVU
Reference: 01.57.471999
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:10

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: 06944413811904
Basic UDI-DI: 69444138ECGCableEVU
Reference: 01.57.471998
EMDN: Z12050380
EMDN description: ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:10

Manufacturer products Authorised representative products Authorised representative actors View details