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06952804828042

Calprotectin FIA

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804828042
Basic UDI-DI: B-06952804828042
Reference: CPT-F23F
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

06952804827892

Zika IgG/IgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827892
Basic UDI-DI: B-06952804827892
Reference: ZIKA-W23M
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

DOA Cup Reader

ADT200，ADT201

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827175
Basic UDI-DI: 69528048ADT200JU
Reference: ADT200，ADT201
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Cholera O1 Antigen Fecal Test Kit

VCO1-F23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827151
Basic UDI-DI: B-06952804827151
Reference: VCO1-F23
EMDN: W0105011799
EMDN description: BACTERIOLOGY IMMUNOASSAY - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

E. histolytica & Giardia lamblia & Crypto Combo Rapid Test Kit

MI-F43001

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827144
Basic UDI-DI: B-06952804827144
Reference: MI-F43001
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device

MI-S45001

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827137
Basic UDI-DI: B-06952804827137
Reference: MI-S45001
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumoniae Antigen Rapid Test

MP-S23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827120
Basic UDI-DI: B-06952804827120
Reference: MP-S23
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Faecal Occult Blood Rapid Test

FOB-F23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827113
Basic UDI-DI: B-06952804827113
Reference: FOB-F23
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Astrovirus Test

ASV-F23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827106
Basic UDI-DI: B-06952804827106
Reference: ASV-F23
EMDN: W0105040629
EMDN description: ASTROVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Test

MI-F44001

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827090
Basic UDI-DI: B-06952804827090
Reference: MI-F44001
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus-Adenovirus-Norovirus Combo test

MI-F43003

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827083
Basic UDI-DI: B-06952804827083
Reference: MI-F43003
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antigens Rapid Test

HP-F23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827076
Basic UDI-DI: B-06952804827076
Reference: HP-F23
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Shigella Rapid Test

SGL-f23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827069
Basic UDI-DI: B-06952804827069
Reference: SGL-f23
EMDN: W0105011714
EMDN description: SHIGELLA
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Campylobacter Rapid Test

CAM-F23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827052
Basic UDI-DI: B-06952804827052
Reference: CAM-F23
EMDN: W0105011401
EMDN description: CAMPYLOBACTER DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

E. coli O157 Rapid Test

ECO-F23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827045
Basic UDI-DI: B-06952804827045
Reference: ECO-F23
EMDN: W0105011599
EMDN description: E. COLI REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

C. difficile GDH Rapid Test

GDH-F23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827038
Basic UDI-DI: B-06952804827038
Reference: GDH-F23
EMDN: W0105011801
EMDN description: C.DIFFICILE GDH DETECTION
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Rapid Test

FLU-S23M

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827021
Basic UDI-DI: B-06952804827021
Reference: FLU-S23M
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test

STB-S23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827014
Basic UDI-DI: B-06952804827014
Reference: STB-S23
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test

STA-S23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827007
Basic UDI-DI: B-06952804827007
Reference: STA-S23
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

06952804825638

Strip, Device

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825638
Basic UDI-DI: 69528048A463101ZT
Reference: A4631011, A46310120, A46310140, A4631021, A46310220, A46310240; A46300120, A46300140, A46300220, A46300240
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Malta
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details