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07.07.2026 16:24

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Patient monitor

BeneVision N22/BeneVision N22 OR/BeneVision N22 ICU/BeneVision N19/BeneVision N19 OR/BeneVision N19 ICU/ BeneVision M22/BeneVision M22C/BeneVision M19/BeneVision M19C

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053037778
Basic UDI-DI: 69449040AB0100002238
Reference: BeneVision M19C
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

Wearable Patient Monitor

EP30

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053037532
Basic UDI-DI: 69449040AB0100001235
Reference: EP30
EMDN: -
EMDN description: TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT 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

Sample Processing System

EU 8600

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053035729
Basic UDI-DI: 69449040AB310000523
Reference: EU 8600
EMDN: -
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

06903053033862

EP300D

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053033862
Basic UDI-DI: 69449040AB051100025W
Reference: EP300
EMDN: -
EMDN description: MONO- AND BIPOLAR DEVICES, SINGLE USE - OTHER
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

Laboratory Data Management Software

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053033848
Basic UDI-DI: 69449040AB3000026ZT
Reference: Laboratory Data Management Software
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
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

06903053035132

TE Air

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053035132
Basic UDI-DI: 69449040AB050100325S
Reference: TE Air
EMDN: -
EMDN description: HANDHELD ULTRASOUND SCANNERS
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

External Defibrillation Paddles

MR6601/MR6603

Class IIbMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053034210
Basic UDI-DI: 69449040AB010000393R
Reference: MR6601 (125-000343-00)
EMDN: -
EMDN description: EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS
First on market country: Austria
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

Chemiluminescence Immunoassay Analyzer

CL-2600i、CL-2800i

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053033787
Basic UDI-DI: 69449040AB4000002ZW
Reference: CL-2600i
EMDN: -
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
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

06903053033343

VMM-ICE-01

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053033343
Basic UDI-DI: 69449040AB050100345W
Reference: VMM-ICE-01
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

Serum Amyloid A Control

105-020947-00、105-021028-00、105-021029-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053029469
Basic UDI-DI: 69449040007C-SAACalCon*6S
Reference: 105-021029-00
EMDN: -
EMDN description: SPECIFIC PROTEIN CONTROLS
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

Serum Amyloid A (SAA) Kit (Latex Particle-Enhanced Immunonephelometry Method)

105-020880-00、105-020881-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053029100
Basic UDI-DI: 69449040007C-SAAS-1****MA
Reference: 105-020881-00
EMDN: -
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
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

Anti-Thyrotropin Receptor Antibody Calibrators

105-010975-00/105-010976-00/105-010214-00/105-020852-00

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: 06903053028004
Basic UDI-DI: 69449040004S-TRAb*****MV
Reference: 105-010214-00
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
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

SC-CAL RET Hematology Calibrator

105-018565-00、105-018566-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053029070
Basic UDI-DI: 69449040AB70000143T
Reference: 105-018565-00
EMDN: -
EMDN description: WHOLE BLOOD CALIBRATORS
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

N-terminal pro B-type natriuretic peptide (CLIA)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053028929
Basic UDI-DI: 69449040AB74000155H
Reference: 105-027044-00
EMDN: -
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
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

06903053028905

LC0005S

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053028905
Basic UDI-DI: 69449040AB0651000487
Reference: LC0005L
EMDN: -
EMDN description: MODULES FOR ENDOSCOPIC IMAGING 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

C-Reactive Protein (CRP) Kit (Latex Particle-Enhanced Immunonephelometry Method）

105-025162-00、105-025161-00、105-025163-00、105-025164-00、105-019037-00、105-019038-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053027236
Basic UDI-DI: 69449040007BCRPC-II****JU
Reference: 105-025162-00
EMDN: -
EMDN description: C-REACTIVE PROTEIN
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

LS LYSE

105-023579-00、105-023578-00

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053027113
Basic UDI-DI: 69449040AB70000103K
Reference: 105-023579-00
EMDN: -
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 10:39

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity C-Reaction Protein（hs-CRP）Kit (Latex Particle-Enhanced Immunonephelometry Method）

105-025167-00、105-019042-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053027076
Basic UDI-DI: 69449040AB70000163X
Reference: 105-025167-00
EMDN: -
EMDN description: HIGH-SENSITIVITY C-.REACTIVE PROTEIN
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

sCD14-ST Calibrators

Please see UDI-DI for details

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053024044
Basic UDI-DI: 69449040009FsCD14-ST***8M
Reference: 105-023905-00
EMDN: -
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
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

06903053023924

NGB-001

Class IMDR 2017/745On the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053023924
Basic UDI-DI: 69449040AB050100355Y
Reference: NGB-055
EMDN: A018002
EMDN description: NEEDLE GUIDES
First on market country: -
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