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45 device results listed.

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LYSUN

BHM-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771209005
Basic UDI-DI: 697177120BHM101B3
Reference: BHM-101
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 31.07.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

Hb Hemoglobin Test Meter

Instrument

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

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983105484
Basic UDI-DI: 6970277510002SYM
Reference: AHR-100
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

06954417600077

MQ-8000

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600077
Basic UDI-DI: 69544176150180YJ
Reference: NA
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

06954417600060

MQ-6000

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600060
Basic UDI-DI: 69544176120160XB
Reference: NA
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

06954417600053

MQ-2000PT

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600053
Basic UDI-DI: 695441760901PT5X
Reference: NA
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

06954417600022

MQ-3000

IVD Class AIVDR 2017/746On the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600022
Basic UDI-DI: 6954417609073023
Reference: NA
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

BGM-202 Blood Glucose Monitoring System

BGM-202

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

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260213221
Basic UDI-DI: 69332602IT0100009A9
Reference: BT0000701
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Hb Hemoglobin Test Meter

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

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05060599403311
Basic UDI-DI: 5060599400002SNZ
Reference: RL-HBM-1A
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 31.07.2026 08:48

Manufacturer products Authorised representative products Authorised representative actors View details

FIALine 100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MDX Netherlands Diagnostics inc
Manufacturer SRN: PH-MF-000050095
UDI-DI: 04806541360308
Basic UDI-DI: 480654136POCTANAQJ
Reference: FIALine 100
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

MDX Hemaline 500S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MDX Netherlands Diagnostics inc
Manufacturer SRN: PH-MF-000050095
UDI-DI: 04806541360001
Basic UDI-DI: 480654136HEMAANAFH
Reference: MDX Hemaline 500S
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin Analyzer

MQ-1000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600435
Basic UDI-DI: 69544176092010Z5
Reference: NA
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 22.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600442
Basic UDI-DI: 69544176092010Z5
Reference: NA
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 22.07.2026 12:28

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Analyzer

Vista

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600381
Basic UDI-DI: 695441761512V13S
Reference: NA
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 17.07.2026 23:48

Manufacturer products Authorised representative products Authorised representative actors View details

Hb Hemoglobin Test Meter

IVD Class ANot specifiedOn the marketInstrumentNear-patient testingProfessional testing

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: 05060599403328
Basic UDI-DI: 5060599400002SNZ
Reference: RL-HBM-1AS
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

06971771201863

BHS-101(25 PCS)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771201863
Basic UDI-DI: B-06971771201863
Reference: BHS-201（25PCS）
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automated CLIA Analyzer Sharay 800

Sharay 800

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testingSingle use

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06980070461984
Basic UDI-DI: 69800704600021T9
Reference: 14000632
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Ireland
Authorised representative: Share info GmbH
Last updated: 16.07.2026 11:29

Manufacturer products Authorised representative products Authorised representative actors View details

06977338230260

Hemoglubin Analyzer

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

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: 06977338230260
Basic UDI-DI: 697733823000CDG
Reference: C21-HB100
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 11:21

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

BHM-102

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771209081
Basic UDI-DI: 697177120BHM102B5
Reference: BHM-102
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglubin Meter

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

Manufacturer: Aceso Laboratories, Inc.
Manufacturer SRN: US-MF-000045175
UDI-DI: 00810164510235
Basic UDI-DI: 0810164510002N5
Reference: EQA01-HB
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 16.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

HB Hemoglobin Test Meter

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

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: 00810047983460
Basic UDI-DI: 0810047980001AG5
Reference: AHR-ACO100
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 03:39

Manufacturer products Authorised representative products Authorised representative actors View details