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07.07.2026 21:23

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CRP Cleanser

105-004887-00、105-011300-00

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415994761
Basic UDI-DI: 69449040AB70000043Q
Reference: 105-011300-00
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: 02.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Digital Cell Morphology Analyzer

MC-80、MC-82

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415988401
Basic UDI-DI: 69449040AB3000005ZK
Reference: MC-80
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:42

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Immunoglobulin E Kit (Particle-enhanced Immunoturbidimetric Assay Method)

105-020853-00、105-002240-00、105-002241-00、105-020854-00、105-004501-00、105-004502-00、105-002309-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986827
Basic UDI-DI: 69449040004JIgE********W8
Reference: 105-020853-00
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

06936415986742

UltraSync

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986742
Basic UDI-DI: 69449040AB050100315Q
Reference: UltraSync
EMDN: Z110603
EMDN description: PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

FUN Control

105-002195-00、105-002196-00、105-002197-00、105-020477-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986476
Basic UDI-DI: 69449040004EFUN********G8
Reference: 105-020477-00
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:42

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CO2 and TBA Multi Control

105-020476-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986452
Basic UDI-DI: 694490400046CO2TBACon**HL
Reference: 105-020476-00
EMDN: W0101050101
EMDN description: ASSAYED MULTICOMPONENT CONTROLS (CC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

AFU Control

please see UDI-DI for details

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415986421
Basic UDI-DI: 694490400043AFU********F3
Reference: 105-020474-00
EMDN: W0101050201
EMDN description: ENZYME CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

06936415979478

HB300R

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415979478
Basic UDI-DI: 69449040AB0651000385
Reference: HB300R
EMDN: Z12020402
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 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

06936415979430

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415979430
Basic UDI-DI: 69449040AB0651000283
Reference: R1
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

06936415977993

DP-10, DP-10T, DP-11, DP-15, DP-18, DP-20, DP-20T, DP-21, DP-25, DP-28, DP-30, DP-30T, DP-36

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977993
Basic UDI-DI: 69449040AB050100135N
Reference: DP-10T
EMDN: Z11040103
EMDN description: PORTABLE ULTRASOUND SCANNERS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Chemiluminescence Immunoassay Analyzer

CL-9000i/CL-9200i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977658
Basic UDI-DI: 69449040AB400000629
Reference: CL-9000i
EMDN: W0201020104
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

BC-7500[B] CRP、BC-7500[N] CRP、BC-7500[R] CRP、BC-7500[NR] CRP、BC-7300[B] CRP、BC-7300[N] CRP、BC-7300[R] CRP、BC-7300[NR] CRP、BC-7500[B] CS、BC-7500[N] CS、BC-7500[R] CS、BC-7500[NR] CS

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977092
Basic UDI-DI: 69449040AB3000011ZE
Reference: BC-7500[B] CRP
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: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

BC-6600Plus、BC-6700Plus、BC-6800Plus

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977054
Basic UDI-DI: 69449040AB3000020ZF
Reference: BC-6600Plus
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: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Hematology Analyzer

BC-5310 CRP、BC-5100 CRP

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415976941
Basic UDI-DI: 69449040AB3000017ZS
Reference: BC-5100 CRP
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: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

06936415973704

DigiEye 680/ DigiEye 680P/ DigiEye 680T/ DigiEye 680E/ DigiEye 760

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415973704
Basic UDI-DI: 69449040AB050100515W
Reference: DigiEye 680
EMDN: Z11031101
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 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

06936415973599

VS 9C

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415973599
Basic UDI-DI: 69449040AB010000443J
Reference: Vital Signs Monitor
EMDN: Z1203020201
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 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

eGateway Integration Manager

eGateway

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415972431
Basic UDI-DI: 69449040AB010000063A
Reference: eGateway
EMDN: Z1203020201
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 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Central Monitoring System

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

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415972417
Basic UDI-DI: 69449040AB010000333D
Reference: BeneVision
EMDN: Z1203020201
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 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

06936415972080

DC-32, DC-30, DC-28, DC-26, DC-25, DC-20, DC-20S, DC-20 Exp, DC-20 Pro, DC-21, DC-22, DC-30S, DC-30 Exp, DC-32S, DC-32 Exp, DC-32 Pro, DC-Bela

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415972080
Basic UDI-DI: 69449040AB050100115J
Reference: DC-20 Exp
EMDN: Z11040104
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 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

06936415971960

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415971960
Basic UDI-DI: 69449040AB065100017Z
Reference: U1
EMDN: Z12020405
EMDN description: SURGICAL CAMERAS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details