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554 device results listed.

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SARS-CoV-2 S-RBD IgG Ab Rapid Test

VCD25-01-013

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VCD25-01-0132R
Basic UDI-DI: B-VCD25-01-0132R
Reference: VCD25-01-013
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Neutralizing Antibody

VCD18

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VCD18ZM
Basic UDI-DI: B-VCD18ZM
Reference: VCD18
EMDN: W0105040699
EMDN description: VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 IgG Rapid Test

VCD24-01-013

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VCD24-01-01326
Basic UDI-DI: B-VCD24-01-01326
Reference: VCD24-01-013
EMDN: W0105090502
EMDN description: CORONAVIRUS ANTIBODY (AB) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:13

Manufacturer products Authorised representative products Authorised representative actors View details

206 Rapid Test

260

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-2606Y
Basic UDI-DI: B-2606Y
Reference: 206-01
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:48

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