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Immunofluorescence Analyzer

DC903A

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000013536
UDI-DI: 06974464590589
Basic UDI-DI: 697446459903PP
Reference: DC903A
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 16:11

Manufacturer products Authorised representative products Authorised representative actors View details

Colloidal gold immunochromatography reader

GIC-S100、GIC-H1W、GIC-H1N、GIC-Q100、GIC-Q100N、GIC-M6、GIC-M6G、GIC-H2、GIC-A1600、GIC-H0、GIC-H0mini

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitNear-patient testing

Manufacturer: Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN: CN-MF-000002230
UDI-DI: 06973602150715
Basic UDI-DI: 697360215GICP5
Reference: GIC-H1N
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:48

Manufacturer products Authorised representative products Authorised representative actors View details

06973316740240

Speedry Immun-chem

IVD Class AIVDR 2017/746Not intended for EU marketInstrumentNear-patient testingProfessional testing

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740240
Basic UDI-DI: 697331674DBIA00CW
Reference: A611011
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

06973316740202

Speedry ImmuFlu

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

Manufacturer: Diasia Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000010281
UDI-DI: 06973316740202
Basic UDI-DI: 697331674FIA02000HZ
Reference: A111011
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

06973224897708

UC100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224897708
Basic UDI-DI: 6973224890050A9
Reference: UC0172
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

06973224897678

UC10

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224897678
Basic UDI-DI: 6973224890049AQ
Reference: UC0171
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

06973224897647

UC1-A UC1-B

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: 06973224897647
Basic UDI-DI: 6973224890048AN
Reference: UC0180
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:25

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

GUKC-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 6971771203065
Basic UDI-DI: 697177120GUKC101PX
Reference: GUKC-102
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 12:19

Manufacturer products Authorised representative products Authorised representative actors View details

LYSUN

GUKC-102

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 6971771203058
Basic UDI-DI: 697177120GUKC102PZ
Reference: GUKC-102
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 12:19

Manufacturer products Authorised representative products Authorised representative actors View details

06971792050105

Portable Quantitative Immunoassay Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Realy Tech Co.,Ltd.
Manufacturer SRN: CN-MF-000004716
UDI-DI: 06971792050105
Basic UDI-DI: 697179205AF3
Reference: RL-A2000
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 12:17

Manufacturer products Authorised representative products Authorised representative actors View details

Liver Function Analysis Meter

LMF-101

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

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: 06971771200200
Basic UDI-DI: 69717712002007Q
Reference: LMF-101
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 12:16

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic HPLC HbA1c Analyzer

GSH-50

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06977125152362
Basic UDI-DI: 697122593GS3596862TX
Reference: GSH-50
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:42

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic HPLC HbA1c Analyzer

GSH-60

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225938970
Basic UDI-DI: 697122593GS35968EF
Reference: GSH-60
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:41

Manufacturer products Authorised representative products Authorised representative actors View details

Glycated Hemoglobin Analyzer

A1c Go

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930127
Basic UDI-DI: 697122593GS35968AMV
Reference: A1c Go
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
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

Hemoglobin Meter

VOM01

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339206862
Basic UDI-DI: 697022176VOM0100001HF
Reference: VOM01-014
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 11:11

Manufacturer products Authorised representative products Authorised representative actors View details

Automated HbA1c Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641479
Basic UDI-DI: 69383846TY006XY
Reference: L-800504
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

POCT HbA1c Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384641448
Basic UDI-DI: 69383846TY004XU
Reference: L-800501
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 10:17

Manufacturer products Authorised representative products Authorised representative actors View details

06934822535560

Compass2800-1, Compass2800-2

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

Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000016839
UDI-DI: 06934822535560
Basic UDI-DI: 693482255660JJ
Reference: Compass2800-1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

06934822535218

Compass3000-1, Compass3000-2

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

Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000016839
UDI-DI: 06934822535218
Basic UDI-DI: 693482255902JK
Reference: Compass3000-1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

06934822535010

Compass2000-1, Compass2000-2

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

Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000016839
UDI-DI: 06934822535010
Basic UDI-DI: 693482255600HY
Reference: Compass2000-1
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details