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338 device results listed.

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Adenovirus Antigen Feces Rapid Test

A49830125, A49830225

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804832056
Basic UDI-DI: 69528048A4983004A
Reference: A49830
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Nasal Rapid Test

A46410120, A46410220

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804832032
Basic UDI-DI: 69528048A46410023
Reference: A464101
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test

A40310125, A40310140, A40310225, A40310240

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804831998
Basic UDI-DI: 69528048A403100XP
Reference: A40310
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test

Format (cassette): A4A411125, A4A411140, A4A411225, A4A411240 Format (strip): A4A410150, A4A410250

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804831967
Basic UDI-DI: 69528048A4A41105L
Reference: Format (cassette): A4A411;Format (strip): A4A410
EMDN: W0105010402
EMDN description: H. PYLORI ANTIBODY ASSAYS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

06952804830489

Multi-drug Urine Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804830489
Basic UDI-DI: B-06952804830489
Reference: MD-U5160
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

G6PD Biosensor Test Meter

G6PD-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804828561
Basic UDI-DI: 69528048G6PD-101KG
Reference: G6PD-101
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 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

Portable Coagulation Analyzer

AS-150C

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804830465
Basic UDI-DI: 69528048AS-150CC9
Reference: AS-150C
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

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