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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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524 device results listed.

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Bladder Tumor Antigen Rapid Test

IVD generalNot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210821
Basic UDI-DI: B-06937339210821
Reference: VTBTA-102
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 08.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Rapid Test

IVD generalNot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210876
Basic UDI-DI: B-06937339210876
Reference: VTFO-U602C
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 08.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Vivadiag

LC-101

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519631448
Basic UDI-DI: B-06975519631448
Reference: LA-137-2
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vivadiag

LC-101

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519631431
Basic UDI-DI: B-06975519631431
Reference: LA-137-1
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vivadiag

LC-101

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519630656
Basic UDI-DI: B-06975519630656
Reference: LA-133-1
EMDN: W0101050202
EMDN description: LIPID CONTROLS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vivadiag

LS-104

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519630410
Basic UDI-DI: B-06975519630410
Reference: LS-133-2
EMDN: W0101060105
EMDN description: TRIGLYCERIDE TEST STRIPS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 23:33

Manufacturer products Authorised representative products Authorised representative actors View details

Vivadiag

LS-103

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519630397
Basic UDI-DI: B-06975519630397
Reference: LS-123-2
EMDN: W0101060103
EMDN description: HDL TEST STRIPS
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

Vivadiag

LS-101

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519630359
Basic UDI-DI: B-06975519630359
Reference: LS-103-2
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - 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

Vivadiag

LP-101/LP-102

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

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06975519630663
Basic UDI-DI: 6975519630001B5C
Reference: LC-103-1/LC-113-1
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 19:14

Manufacturer products Authorised representative products Authorised representative actors View details

Portable FIA Analyzer

VIM300H

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210593
Basic UDI-DI: 697022176VIM300H00001MF
Reference: VIM300H-00-01
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 11:11

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

POCT Analyzer

VIM1000M6

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339204172
Basic UDI-DI: 697022176VIM1000001D9
Reference: VIM1000M6-00-011
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
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

POCT Multifunction Meter VIM220H

VIM220H

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339204134
Basic UDI-DI: 697022176VIM220H001KM
Reference: VIM220H-00-011
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
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

POCT Analyzer VIM3000

VIM3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339200808
Basic UDI-DI: 697022176VIM300000011C7
Reference: VIM3000-00-011
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
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

FOB Rapid Test

VTFO

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221769106
Basic UDI-DI: B-06970221769106
Reference: VTFO-U602
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 29.06.2026 23:36

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Influenza A+B/RSV/Adenovirus Ag Combo Rapid Test

VISIRA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221768963
Basic UDI-DI: B-06970221768963
Reference: VISIRA-757
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 29.06.2026 23:36

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test

VISIR

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221768956
Basic UDI-DI: B-06970221768956
Reference: VISIR-737
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 29.06.2026 23:36

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test

VISIR

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221768949
Basic UDI-DI: B-06970221768949
Reference: VISIR-737
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 29.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

Wielofunkcyjny Glukometr Szpitalny VivaChek Pro

VGM9802

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221768703
Basic UDI-DI: 697022176VGM9802000226
Reference: VGM9802-725
EMDN: W020106019099
EMDN description: VARIOUS DIABETES MONITORING INSTRUMENTS - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 29.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details

Płyn kontrolny do pomiaru stężenia glukozy we krwi VivaChek Fad

VGC02

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06970221768697
Basic UDI-DI: B-06970221768697
Reference: VGC02-031
EMDN: W010106010801
EMDN description: BLOOD TEST STRIPS CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 29.06.2026 23:35

Manufacturer products Authorised representative products Authorised representative actors View details