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102 device results listed.

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KEYU Feces Analyzer

Feces Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735360019
Basic UDI-DI: 697473536KUA01P4
Reference: KU-F20
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® ElectroMeter Plus

Q-2 Plus

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168135
Basic UDI-DI: 697470316Q-2PlusTN
Reference: Q-2 Plus
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® ElectroMeter

Q-1 Pro

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168128
Basic UDI-DI: 697470316Q-1ProHA
Reference: Q-1 Pro
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® ElectroMeter

Q-3 Plus

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168111
Basic UDI-DI: 697470316Q-3PlusTZ
Reference: Q-3 Plus
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® ElectroMeter

Q-3 Pro

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

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703168104
Basic UDI-DI: 697470316Q-3ProHQ
Reference: Q-3 Pro
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 02.07.2026 17:17

Manufacturer products Authorised representative products Authorised representative actors View details

06972719603725

A6I

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Nanjing RealMind Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000024838
UDI-DI: 06972719603725
Basic UDI-DI: 6972719600091BJ
Reference: A6I
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginitis Detection System

LTS-V400

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 06972235844244
Basic UDI-DI: 697223584V400GZ
Reference: LTS-V400
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 12:38

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

CA-80 Semi-auto Chemistry Analyzer

CA-80、URIT-880

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740718707
Basic UDI-DI: 69357407ICA000003K7
Reference: /
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:03

Manufacturer products Authorised representative products Authorised representative actors View details

QSight 225 MD UHPLC Screening System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147384709
Basic UDI-DI: 6438147QSight_2254T
Reference: 2040-0030
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

QSight 210 MD Screening System

IVD Class AIVDR 2017/746No longer on the marketInstrumentProfessional testing

Manufacturer: Wallac Oy
Manufacturer SRN: FI-MF-000022620
UDI-DI: 06438147371815
Basic UDI-DI: 6438147QSight_2104E
Reference: 2040-0010
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:04

Manufacturer products View details

AviChem Midi

IVD Class AIVDR 2017/746Not intended for EU marketInstrument

Manufacturer: Avicenna
Manufacturer SRN: AE-MF-000026668
UDI-DI: 06290360050010
Basic UDI-DI: 629036005AVIMIDI300010W8
Reference: AVI-MIDI
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

AviChem Mini

IVD Class AIVDR 2017/746Not intended for EU marketInstrument

Manufacturer: Avicenna
Manufacturer SRN: AE-MF-000026668
UDI-DI: 06290360050003
Basic UDI-DI: 629036005AVIMINI15000359
Reference: AVI-MINI
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 08:40

Manufacturer products Authorised representative products Authorised representative actors View details

URIT-880 Semi-auto Chemistry Analyzer

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: URIT Medical Electronic Co.,Ltd.
Manufacturer SRN: CN-MF-000011840
UDI-DI: 06935740718714
Basic UDI-DI: 69357407ICA000003K7
Reference: /
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 14:58

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal Secretion Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zhuhai Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000026852
UDI-DI: 06972235843780
Basic UDI-DI: 697223584V900HS
Reference: LTS-V900B
EMDN: W02010199
EMDN description: CHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.06.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details