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Diagnostic Ultrasound System

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413835504
Basic UDI-DI: 69444138AcclarixGX9SD8
Reference: Acclarix GX9 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 12:36

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: 06944413835498
Basic UDI-DI: 69444138AcclarixGX9SD8
Reference: Acclarix GX9
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 12:36

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: 06944413835474
Basic UDI-DI: 69444138UTGG
Reference: E10-3Q
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 12:36

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: 06944413835467
Basic UDI-DI: 69444138ConCableBK
Reference: IBP12HO11
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 12:36

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: 06944413835450
Basic UDI-DI: 69444138ConCableBK
Reference: IBP12ED11
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 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

H80

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413835436
Basic UDI-DI: 69444138H80SPS
Reference: H88S
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

H80

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413835429
Basic UDI-DI: 69444138H80SPS
Reference: H88
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

H80

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413835412
Basic UDI-DI: 69444138H80SPS
Reference: H80S
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

H80

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413835405
Basic UDI-DI: 69444138H80SPS
Reference: H80
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Patient Monitor

Neptune

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413835344
Basic UDI-DI: 69444138Neptune8E
Reference: Neptune
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 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Trolley (for medical use)

Class IMDR 2017/745On the market

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413835276
Basic UDI-DI: 69444138MT805SNV
Reference: MT-818
EMDN: Z11049080
EMDN description: VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Telemetry Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413835214
Basic UDI-DI: 69444138iT30SYS
Reference: iT50
EMDN: Z1203020202
EMDN description: TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Telemetry Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413835153
Basic UDI-DI: 69444138iT30SYS
Reference: iT30
EMDN: Z1203020202
EMDN description: TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Sampler

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413834774
Basic UDI-DI: 69444138isafeCsCD
Reference: isafeC-100BN
EMDN: W0501010203
EMDN description: BLOOD COLLECTION, CAPILLARY TUBES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Sampler

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413834767
Basic UDI-DI: 69444138isafeCsCD
Reference: isafeC-85AN
EMDN: W0501010203
EMDN description: BLOOD COLLECTION, CAPILLARY TUBES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Sampler

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413834750
Basic UDI-DI: 69444138isafeCsCD
Reference: isafeC-115BY
EMDN: W0501010203
EMDN description: BLOOD COLLECTION, CAPILLARY TUBES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:36

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Sampler

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testingSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413834743
Basic UDI-DI: 69444138isafeCsCD
Reference: isafeC-100AY
EMDN: W0501010203
EMDN description: BLOOD COLLECTION, CAPILLARY TUBES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

EMG/Stimulation sensor

Class IMDR 2017/745On the marketActive device

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413834736
Basic UDI-DI: 69444138SKS5Q
Reference: SK5050WF-F
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 12:35

Manufacturer products Authorised representative products Authorised representative actors View details

Patient Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413834415
Basic UDI-DI: 69444138iV12SZ4
Reference: iV17
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 12:35

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: 06944413834200
Basic UDI-DI: 69444138ConCableBK
Reference: 01.57.472024
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 12:35

Manufacturer products Authorised representative products Authorised representative actors View details