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65 device results listed.

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Allergen-Specific IgE Antibody Calibrator Kit (Fluorescence flow cytometry)

25 tests/kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117454996
Basic UDI-DI: B-06976117454996
Reference: MY-0018-01
EMDN: W02020601
EMDN description: RAPID TEST CELL COUNT INSTRUMENTS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 07.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Testing System

BC-202

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: Hangzhou Bosure Biotech Co., Ltd
Manufacturer SRN: CN-MF-000003001
UDI-DI: 06975519631172
Basic UDI-DI: B-06975519631172
Reference: BC-211-1
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: 06.07.2026 23:33

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Testing System

BC-102

IVD generalIVDDOn the marketInstrumentKitProfessional testing

Manufacturer: Hangzhou Bosure Biotech Co., Ltd
Manufacturer SRN: CN-MF-000003001
UDI-DI: 06975519630052
Basic UDI-DI: B-06975519630052
Reference: BC-111-1
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:32

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Testing System

BC-101

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testing

Manufacturer: Hangzhou Bosure Biotech Co., Ltd
Manufacturer SRN: CN-MF-000003001
UDI-DI: 06975519630038
Basic UDI-DI: B-06975519630038
Reference: BC-101-1
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:32

Manufacturer products Authorised representative products Authorised representative actors View details

06954417600114

IVD Class ANot specifiedOn the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600114
Basic UDI-DI: 6954417609073023
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: 06.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

06954417600121

IVD Class ANot specifiedOn the marketDirect markingHuman tissuesInstrumentProfessional testing

Manufacturer: Shanghai Medconn Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000038658
UDI-DI: 06954417600121
Basic UDI-DI: 69544176150180YJ
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: 06.07.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

CoaguChek XS System

IVD self-testing devicesIVDDOn the marketInstrumentNear-patient testingSelf testing

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 04015630945719
Basic UDI-DI: B-04015630945719
Reference: 04625412170
EMDN: W02020602
EMDN description: RAPID TEST HEMOSTASIS INSTRUMENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.07.2026 22:42

Manufacturer products View details

CoaguChek INRange

IVD self-testing devicesIVDDOn the marketInstrumentSelf testing

Manufacturer: Roche Diagnostics GmbH
Manufacturer SRN: DE-MF-000006260
UDI-DI: 04015630942251
Basic UDI-DI: B-04015630942251
Reference: 07404379170
EMDN: W02020602
EMDN description: RAPID TEST HEMOSTASIS INSTRUMENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.07.2026 22:42

Manufacturer products View details

HbChek

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biosense Technologies Private Limited.
Manufacturer SRN: IN-MF-000052180
UDI-DI: 08908015864094
Basic UDI-DI: 8908015864HBCHEKMETER74
Reference: FG00061
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Estonia
Authorised representative: MD&D Alliance GmbH
Last updated: 03.07.2026 22:07

Manufacturer products Authorised representative products Authorised representative actors View details

08809446082135

BHN-E00182

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: WELLS BIO, INC.
Manufacturer SRN: KR-MF-000031789
UDI-DI: 08809446082135
Basic UDI-DI: 880944608BAH0X0DW
Reference: BHN-E00182
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 03.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

AI Morphology analyzer

SA1

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

Manufacturer: Seamaty Diagnostic Technology (Chengdu) Co., Ltd.
Manufacturer SRN: CN-MF-000047425
UDI-DI: 06978848020457
Basic UDI-DI: 6978848020457HT
Reference: A00500000EN0
EMDN: W02020601
EMDN description: RAPID TEST CELL COUNT INSTRUMENTS
First on market country: Germany
Authorised representative: GRZAN GmbH
Last updated: 03.07.2026 00:05

Manufacturer products Authorised representative products Authorised representative actors View details

06977367850033

TG-10,TG-60

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Changchun Chenyu Taikang Medical Laboratory Co., Ltd
Manufacturer SRN: CN-MF-000046653
UDI-DI: 06977367850033
Basic UDI-DI: 697736785GHA001NZ
Reference: TG-10
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:30

Manufacturer products Authorised representative products Authorised representative actors View details

Landing

Cytology and Histology Image Processing Software

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Wuhan Landing Intelligence Medical Co., Ltd.
Manufacturer SRN: CN-MF-000030678
UDI-DI: 06975866146114
Basic UDI-DI: 697586614MIS006T6
Reference: 611
EMDN: W02020692
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:12

Manufacturer products Authorised representative products Authorised representative actors View details

06975519631165

BC-201、BC-202、BC-203

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

Manufacturer: Hangzhou Bosure Biotech Co., Ltd
Manufacturer SRN: CN-MF-000003001
UDI-DI: 06975519631165
Basic UDI-DI: 6975519630005B5Q
Reference: BC-201-1
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 19:14

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automated CLIA Analyzer

Sharay 6000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070765484
Basic UDI-DI: 697507076000317S4
Reference: 18920001
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automated CLIA Analyzer

Sharay 8000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: C-Luminary Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000035089
UDI-DI: 06975070765477
Basic UDI-DI: 697507076000316S2
Reference: 18920002
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

06933260214044

UAM-02

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

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214044
Basic UDI-DI: 69332602IT01000119U
Reference: BT0000901
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

06933260214037

BKM-02

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

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260214037
Basic UDI-DI: 69332602IT01000109S
Reference: BT0000801
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

Hb Hemoglobin Test Meter

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983105491
Basic UDI-DI: 6970277510002SYM
Reference: AHR-100ST
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 14:17

Manufacturer products Authorised representative products Authorised representative actors View details

Auto Immuno Hematology Analyzer

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377301717
Basic UDI-DI: B-06941377301717
Reference: PO-0015-03
EMDN: W02020601
EMDN description: RAPID TEST CELL COUNT INSTRUMENTS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 25.06.2026 07:16

Manufacturer products Authorised representative products Authorised representative actors View details