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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

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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

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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

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Controls

Blood Gas and Electrolyte Control Level 2

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809086
Basic UDI-DI: B-06944413809086
Reference: Blood Gas and Electrolyte Control Level 2
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

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Blood Gas and Electrolyte Control Level 1

IVD generalIVDDOn the marketNear-patient testingProfessional testingReagentSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809079
Basic UDI-DI: B-06944413809079
Reference: Blood Gas and Electrolyte Control Level 1
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

ultrasonic transducer

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809055
Basic UDI-DI: 69444138UTGG
Reference: MC9-3TQ
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 12:07

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ultrasonic transducer

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809031
Basic UDI-DI: 69444138UTGG
Reference: P7-3Q
EMDN: Z110402010301
EMDN description: TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:07

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ultrasonic transducer

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413809000
Basic UDI-DI: 69444138UTGG
Reference: P5-1Q
EMDN: Z110402010301
EMDN description: TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL
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

Vital Signs Monitor

iM3

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413808812
Basic UDI-DI: 69444138iM36M
Reference: iM3
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 12:07

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Electrocardiograph

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413808980
Basic UDI-DI: 69444138SE15SPT
Reference: SL18A
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 12:07

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Electrocardiograph

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413808966
Basic UDI-DI: 69444138SE1201GE
Reference: SL12A
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 12:07

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: 06944413808911
Basic UDI-DI: 69444138ECGCableEVU
Reference: 01.57.471877
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 12:07

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: 06944413808904
Basic UDI-DI: 69444138ECGCableEVU
Reference: 01.57.471876
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 12:07

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: 06944413808393
Basic UDI-DI: 69444138C3SYY
Reference: C6 HD
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

ultrasonic transducer

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413808218
Basic UDI-DI: 69444138UTGG
Reference: L12-5Q
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 12:07

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: 06944413808409
Basic UDI-DI: 69444138C3SYY
Reference: C6A HD
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

06944413808768

SD1

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413808768
Basic UDI-DI: 69444138SD12Z
Reference: SD1
EMDN: Z12080103
EMDN description: FOETAL HEARTBEAT DETECTORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:06

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: 06944413808201
Basic UDI-DI: 69444138UTGG
Reference: MC8-4Q
EMDN: Z110402010201
EMDN description: CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY)
First on market country: Denmark
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:06

Manufacturer products Authorised representative products Authorised representative actors View details

Data Management Software

Smart ECG Net

Class IMDR 2017/745On the marketActive device

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413808140
Basic UDI-DI: 69444138SmartECGNetYE
Reference: Smart ECG Net
EMDN: Z12030292
EMDN description: VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:06

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: 06944413807679
Basic UDI-DI: 69444138SE2003SFG
Reference: SE-2003A
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 12:06

Manufacturer products Authorised representative products Authorised representative actors View details