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543 device results listed.

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Cardiac Combo (cTnI/NT-proBNP) Test Kit (FIA)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339209092
Basic UDI-DI: B-06937339209092
Reference: VID215-03-011
EMDN: W0102160706
EMDN description: MULTIPLE CARDIAC MARKERS - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

High Sensitivity Cardiac Troponin I Test Kit (FIA)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339209085
Basic UDI-DI: B-06937339209085
Reference: VID113-03-011
EMDN: W0102160703
EMDN description: TROPONIN I/T - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Fad Blood Glucose Test Strips

IVD Annex II List BNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339208767
Basic UDI-DI: B-06937339208767
Reference: VGS02-039
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Fad Blood Glucose Test Strips

IVD Annex II List BNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339208750
Basic UDI-DI: B-06937339208750
Reference: VGS02-033
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek Fad Blood Glucose Test Strips

IVD Annex II List BNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339208743
Basic UDI-DI: B-06937339208743
Reference: VGS02-034
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

VivaChek FAD Blood Glucose Meter

IVD Annex II List BNot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339208521
Basic UDI-DI: B-06937339208521
Reference: VGM03-036
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Testing System

IVD generalNot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207739
Basic UDI-DI: B-06937339207739
Reference: VOM01-013
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Testing System

IVD generalNot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207722
Basic UDI-DI: B-06937339207722
Reference: VOM01-011
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin Meter

IVD Class ANot specifiedOn the market

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207715
Basic UDI-DI: 697022176VOM0100001HF
Reference: VOM01-012
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Multiplex Respiratory Antigen Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207630
Basic UDI-DI: B-06937339207630
Reference: VIRI-7117
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Multiplex Respiratory Antigen Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207623
Basic UDI-DI: B-06937339207623
Reference: VIRI-7107
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

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

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207616
Basic UDI-DI: B-06937339207616
Reference: VIRI-737-002
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Combo Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207609
Basic UDI-DI: B-06937339207609
Reference: VIRA-627
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Pregnancy Rapid Test Midstream

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207593
Basic UDI-DI: B-06937339207593
Reference: VHHC-103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

hLH Ovulation Rapid Test Midstream

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207586
Basic UDI-DI: B-06937339207586
Reference: VHLH-103H
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus/Rotavirus/Adenovirus/Astrovirus Combo Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207579
Basic UDI-DI: B-06937339207579
Reference: VINRAA-647
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Norovirus Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207562
Basic UDI-DI: B-06937339207562
Reference: VINO-602
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207555
Basic UDI-DI: B-06937339207555
Reference: VIFLa-702
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

HCG one step pregnancy Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207548
Basic UDI-DI: B-06937339207548
Reference: VHHC-502
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

C. difficile Toxin A/B Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339207531
Basic UDI-DI: B-06937339207531
Reference: VICT-627
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details