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06903053042871

FS-U

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053042871
Basic UDI-DI: 69449040AB0511000564
Reference: FS-S
EMDN: K020299
EMDN description: DEVICES FOR SURGERY WITH ULTRASONIC GENERATOR, SINGLE-USE - OTHER
First on market country: Netherlands
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

06903053047081

HB500

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053047081
Basic UDI-DI: 69449040AB065100098H
Reference: HB300
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

06903053043489

uMEC 30

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053043489
Basic UDI-DI: 69449040AB010000473Q
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 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Coagulation Analyzer

CX-6000、CX-6010、CX-6200、CX-6210

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053043045
Basic UDI-DI: 69449040AB320000128
Reference: CX-6000
EMDN: -
EMDN description: AUTOMATED COAGULOMETERS
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

06903053042024

Resona A10S

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053042024
Basic UDI-DI: 69449040AB050100435X
Reference: Resona AR
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 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

Humidification Chamber

HF1101,HF1103,HF1104

Class IIaMDR 2017/745On the marketMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053041300
Basic UDI-DI: 69449040AB0200004545
Reference: HF1101
EMDN: -
EMDN description: HUMIDIFICATION SYSTEMS - ACCESSORIES
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

Nasal cannula

Please see UDI-DI for details

Class IIaMDR 2017/745On the marketMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053041133
Basic UDI-DI: 69449040AB020000333W
Reference: HF132S
EMDN: -
EMDN description: HIGH FLOW THERAPY NASAL CANNULAS (HFNC)
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

06903053040747

Recho R9W

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053040747
Basic UDI-DI: 69449040AB050100445Z
Reference: Recho R9W
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 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

06903053039888

CT-01

Class IMDR 2017/745On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039888
Basic UDI-DI: 69449040AB0511000666
Reference: CT-01
EMDN: Y120612
EMDN description: WALKING TROLLEYS
First on market country: Netherlands
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

Auto Hematology Analyzer

BC-5390, Counter 31 AL

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053040716
Basic UDI-DI: 69449040AB3000015ZN
Reference: Counter 31 AL
EMDN: -
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: 02.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

BC-5000、BC-5120、BC-5130、BC-5140、BC-5150、Unicorn 5、Counter 29、Mispa CountZ

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053040693
Basic UDI-DI: 69449040AB3000010ZC
Reference: Unicorn 5
EMDN: -
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: 02.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053040648
Basic UDI-DI: 69449040AB3000013ZJ
Reference: Counter XS 20
EMDN: -
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: 02.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

CD80 DETERGENT

105-000748-00、105-000107-00、004C-30-88618、004C-30-88619、105-000106-00、105-011705-00

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039819
Basic UDI-DI: 69449040004CCD80*******FY
Reference: 105-035958-00
EMDN: -
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)
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

Herpes Simplex Virus-1 IgG（CLIA）

105-012500-00、105-012501-00、105-012503-00、105-012504-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039574
Basic UDI-DI: 69449040AB740001159
Reference: 105-012503-00
EMDN: -
EMDN description: HSV 1 IGG
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

Herpes Simplex Virus 1+2 IgG（CLIA）

105-012494-00、105-012495-00、105-012497-00、105-012498-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039550
Basic UDI-DI: 69449040AB74000135D
Reference: 105-012498-00
EMDN: -
EMDN description: HSV 1+2 IGG
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

Herpes Simplex Virus-2 IgG（CLIA）

105-012506-00 、105-012507-00、105-012509-00、105-012510-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039529
Basic UDI-DI: 69449040AB74000125B
Reference: 105-012509-00
EMDN: -
EMDN description: HSV 2 IGG
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

Herpes Simplex Virus 1+2 IgM（CLIA）

105-012488-00、105-012489-00、105-012491-00、105-012492-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039512
Basic UDI-DI: 69449040AB74000145F
Reference: 105-012489-00
EMDN: -
EMDN description: HSV 1+2 IGM
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

06903053038645

DigiEye 330 / DigiEye 330E / DigiEye 330P / DigiEye 330T / DigiEye 350 / DigiEye 350E / DigiEye 350P / DigiEye 350T / DigiEye 360 / DigiEye 360E / DigiEye 360P / DigiEye 360T

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053038645
Basic UDI-DI: 69449040AB0601000466
Reference: DigiEye 330E
EMDN: -
EMDN description: MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
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

Flow Sensor

Please see UDI-DI for details

Class IIaMDR 2017/745On the marketMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053038126
Basic UDI-DI: 69449040AB010000073C
Reference: RM11105
EMDN: -
EMDN description: PULMONARY VENTILATORS FOR HOSPITAL USE - CONSUMABLES
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

Airway Adapter

60-14200-00 / 60-14100-00 / 040-001187-00 / GA3201 / GA3202 / GA3211 / GA3212 / GA 3501

Class IMDR 2017/745On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053038010
Basic UDI-DI: 69449040AB0100000334
Reference: GA3201（040-006828-00）
EMDN: -
EMDN description: MULTI-PARAMETER MONITORS - CONSUMABLES
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