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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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Lyse

HL310

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413814028
Basic UDI-DI: 69444138HL310KD
Reference: HL310
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaner

HC600

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813953
Basic UDI-DI: 69444138HC600HS
Reference: HC600
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

Cleaner

HC600

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813922
Basic UDI-DI: 69444138HC600HS
Reference: HC600
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

Lyse

HL600

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813915
Basic UDI-DI: 69444138HL600KR
Reference: HL600
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

Lyse

HL600

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813908
Basic UDI-DI: 69444138HL600KR
Reference: HL600
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

EMG/Stimulation sensor

Class IIaMDR 2017/745On the marketActive deviceSingle use

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813854
Basic UDI-DI: 69444138ESS4A
Reference: SV1
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 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

EMG/Stimulation sensor

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813595
Basic UDI-DI: 69444138ESS4A
Reference: SV24
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 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

EMG/Stimulation sensor

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813564
Basic UDI-DI: 69444138ESS4A
Reference: SV2
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 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

Diluent

HD600

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813502
Basic UDI-DI: 69444138HD600HZ
Reference: HD600
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

Lyse

HL600

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813489
Basic UDI-DI: 69444138HL600KR
Reference: HL600
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

Lyse

HL600

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813472
Basic UDI-DI: 69444138HL600KR
Reference: HL600
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 27.06.2026 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

Vital Signs Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813465
Basic UDI-DI: 69444138iM3SS2J
Reference: iHM3s
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 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

Vital Signs Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813458
Basic UDI-DI: 69444138iM3SS2J
Reference: iM3Bs
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 12:13

Manufacturer products Authorised representative products Authorised representative actors View details

Vital Signs Monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Edan Instruments,Inc.
Manufacturer SRN: CN-MF-000009957
UDI-DI: 06944413813441
Basic UDI-DI: 69444138iM3SS2J
Reference: iM3As
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 12:13

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: 06944413813342
Basic UDI-DI: 69444138AcclarixLX3SDR
Reference: Acclarix LX28
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 12:12

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: 06944413813328
Basic UDI-DI: 69444138AcclarixLX3SDR
Reference: Acclarix LX25
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 12:12

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: 06944413813311
Basic UDI-DI: 69444138AcclarixLX3SDR
Reference: Acclarix LX3 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 12:12

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: 06944413813304
Basic UDI-DI: 69444138AcclarixLX3SDR
Reference: Acclarix LX3 Super
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 12:12

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: 06944413813298
Basic UDI-DI: 69444138AcclarixLX3SDR
Reference: Acclarix LX3
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 12:12

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: 06944413813281
Basic UDI-DI: 69444138ECGCablePWJ
Reference: 01.57.471744
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 12:12

Manufacturer products Authorised representative products Authorised representative actors View details