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Vaginal Secretion Analyzer

LTS-V900A，LTS-V900B

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 06972235843773
Basic UDI-DI: 697223584V900HS
Reference: LTS-V900A
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 12:37

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Vaginal Secretion Analyzer

LTS-V800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 06972235841595
Basic UDI-DI: 697223584V800HM
Reference: LTS-V800
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 12:37

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Chemistry Analyzer

C 400, C410, C 600, C 610, C 1000, C 1100

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168358009
Basic UDI-DI: 69721683510059S
Reference: CH9201105
EMDN: W0201010103
EMDN description: CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h > 800 and <= 1.200)
First on market country: Türkiye
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

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Semi-Automatic Urine Analyzer

U 350; U 370; U 390

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168355466
Basic UDI-DI: 6972168352202A5
Reference: EHU9101004
EMDN: W020101020102
EMDN description: SEMI-AUTOMATED URINE ANALYSERS
First on market country: Türkiye
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

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Automatic Urinalysis System

U 2000, U 2000S

IVD Class BIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Maccura Medical Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000028087
UDI-DI: 06972168352106
Basic UDI-DI: 6972168352201A3
Reference: EHU9101007
EMDN: W020101020103
EMDN description: AUTOMATED URINE ANALYSERS
First on market country: Türkiye
Authorised representative: Humiss International B.V.
Last updated: 02.07.2026 12:35

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Immunoassay Protein Analyzer

LTS-C100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hunan Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000029972
UDI-DI: 06972129852300
Basic UDI-DI: 697212985C100DJ
Reference: LTS-C100
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Immunofluoresecence Quantitative Analyzer

LTS-IF160, LTS-IF80, LTS-IF10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hunan Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000029972
UDI-DI: 06972129852119
Basic UDI-DI: 697212985IF22
Reference: LTS-IF160
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 12:34

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Sinnowa

DS-161, DS-261, DS- 301, DS-401,DS- 405,DS-612，DS- 812,BS-3000M，BS- 3000P,BS-3000,CH- 12，CH-24

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SINNOWA Medical Science & Technology Co., Ltd
Manufacturer SRN: CN-MF-000032436
UDI-DI: 06971385381128
Basic UDI-DI: 697138538BA001AZ
Reference: N/A
EMDN: W0201010192
EMDN description: CHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Belgium
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 11:55

Manufacturer products Authorised representative products Authorised representative actors View details

GBA-1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930325
Basic UDI-DI: 697122593GS5667601TN
Reference: GBA-1000
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

MNCHIP

Pointcare M4

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Tianjin MNCHIP Technologies Co.,Ltd
Manufacturer SRN: CN-MF-000029863
UDI-DI: 69703904810142
Basic UDI-DI: 69703904810148E
Reference: 110033
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 11:19

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MNCHIP

Celercare M5

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Tianjin MNCHIP Technologies Co.,Ltd
Manufacturer SRN: CN-MF-000029863
UDI-DI: 69703904801850
Basic UDI-DI: 697039048018593
Reference: 110049
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 11:19

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977467
Basic UDI-DI: 69449040SHYQ-BA83******QM
Reference: BS-810
EMDN: W0201010107
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 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977375
Basic UDI-DI: 69449040SHYQ-BA43******N9
Reference: BS-410
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415972202
Basic UDI-DI: 69449040SHYQ-BA3K******ZV
Reference: BS-2600M
EMDN: W0201010108
EMDN description: CHEMISTRY ANALYSERS - HIGH ROUTINE (with ISE mode test/h > 1.200)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977368
Basic UDI-DI: 69449040SHYQ-BA38******QB
Reference: BS-390
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

Chemistry Analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415977238
Basic UDI-DI: 69449040SHYQ-BA2M******2F
Reference: BS-2200
EMDN: W0201010106
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:46

Manufacturer products Authorised representative products Authorised representative actors View details

06935740744324

URIT-DC4

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740744324
Basic UDI-DI: 69357407ICAS000044B2
Reference: /
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740744300

URIT-DC3

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740744300
Basic UDI-DI: 69357407ICAS000043AY
Reference: /
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740739573

Detergent for Electrolyte Analyzer

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740739573
Basic UDI-DI: 69357407ICAS000042AW
Reference: /
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

06935740735360

UD-2300

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740735360
Basic UDI-DI: 69357407IUD000002XE
Reference: /
EMDN: W0201010202
EMDN description: URINARY SEDIMENT DEVICES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details