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Automated Blood Culture System

FA-N60、FA-N120、FA-N240

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053070430
Basic UDI-DI: 69449040AB41000032G
Reference: FA-N120
EMDN: -
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

06903053064118

DigiEye 310

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053064118
Basic UDI-DI: 69449040AB050100425V
Reference: DigiEye 310
EMDN: -
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

06903053064101

RetroPad

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053064101
Basic UDI-DI: 69449040AB050100415T
Reference: RetroPad
EMDN: -
EMDN description: BIOIMAGING PROCESSORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

06903053063838

Nuewa A20W

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053063838
Basic UDI-DI: 69449040AB0501004767
Reference: Nuewa A Super
EMDN: -
EMDN description: MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

06903053062305

BeneVision N1

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053062305
Basic UDI-DI: 69449040AB0100002034
Reference: Patient Monitor
EMDN: -
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Dosing System

AP-100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053062220
Basic UDI-DI: 69449040AB41000012C
Reference: AP-100
EMDN: -
EMDN description: AUTOSAMPLERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Automated ID/AST Testing System

AF-300，AF-360，AF-600，AF-660

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053062213
Basic UDI-DI: 69449040AB41000022E
Reference: AF-300
EMDN: -
EMDN description: ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Renin (CLIA)

105-031482-00、105-031483-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053062008
Basic UDI-DI: 69449040AB74000095N
Reference: 105-031482-00
EMDN: -
EMDN description: RENINE (PLASMA RENINE ACTIVITY)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Aldosterone (CLIA)

105-029848-00/105-031481-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053061988
Basic UDI-DI: 69449040AB74000085L
Reference: 105-029848-00
EMDN: -
EMDN description: ALDOSTERONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Trolley

Please see UDI-DI for details

Class IMDR 2017/745On the marketMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053059879
Basic UDI-DI: 69449040AB0200003746
Reference: 045-005884-00
EMDN: -
EMDN description: NON-MOTORIZED VEHICLES AND MEANS OF TRANSPORT - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Laboratory Automation System

MT 8000

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053058476
Basic UDI-DI: 69449040AB400000323
Reference: MT 8000
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

06903053057332

a3P-X

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053057332
Basic UDI-DI: 69449040AB0501003764
Reference: a3P-X
EMDN: -
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: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

BS-1000M、BS-1100M

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053053044
Basic UDI-DI: 69449040AB4000001ZU
Reference: BS-1000M
EMDN: -
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

4K 3D Video Endoscope

M 31030A, M 31000A, M 31030PA, M 31000PA, G 31030A, G 31000A, G 31030PA, G 31000PA

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053050883
Basic UDI-DI: 69449040AB065100068B
Reference: G 31000A
EMDN: -
EMDN description: VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:40

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Urinalysis System

EU-5600pro

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053050715
Basic UDI-DI: 69449040AB3100004ZW
Reference: EU-5300pro
EMDN: -
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

HLA-B27 Reagent

105-034921-00

IVD Class BIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053047418
Basic UDI-DI: 69449040AB70000033N
Reference: 105-034921-00
EMDN: -
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

CD3-FITC/CD16+56-PE/CD45-PerCP/CD19-APC Reagent

105-035114-00

IVD Class CIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053047401
Basic UDI-DI: 69449040AB70000023L
Reference: 105-035114-00
EMDN: -
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

CD3-FITC/CD8-PE/CD45-PerCP/CD4-APC Reagent

105-035033-00

IVD Class CIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053047395
Basic UDI-DI: 69449040AB70000013J
Reference: 105-035033-00
EMDN: -
EMDN description: ANTIBODIES FOR B AND T-CELL SUBTYPING
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

06903053047265

HB500R

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053047265
Basic UDI-DI: 69449040AB065100088F
Reference: HB500R
EMDN: -
EMDN description: LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

06903053047128

UX7

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053047128
Basic UDI-DI: 69449040AB065100078D
Reference: UX3-SIM
EMDN: -
EMDN description: INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details