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411 device results listed.

Page 21 / 21

Ketamine (KET) Chemiluminescence Immunoassay Test Kit

G302A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802431
Basic UDI-DI: B-06952804802431
Reference: G302A08
EMDN: W0102160502
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Methamphetamine (MET) Chemiluminescence Immunoassay Test Kit

G301A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802424
Basic UDI-DI: B-06952804802424
Reference: G301A08
EMDN: W0102160502
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Morphine (MOR) Chemiluminescence Immunoassay Test Kit

G300A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802417
Basic UDI-DI: B-06952804802417
Reference: G300A08
EMDN: W0102090112
EMDN description: MORPHINES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

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Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Test Kit

G022A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802400
Basic UDI-DI: B-06952804802400
Reference: G022A08
EMDN: W01021314
EMDN description: ST2
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Test Kit

G107A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802394
Basic UDI-DI: B-06952804802394
Reference: G107A08
EMDN: W01021312
EMDN description: LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Folate Chemiluminescence Immunoassay Test Kit

G702A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802387
Basic UDI-DI: B-06952804802387
Reference: G702A08
EMDN: W0102070103
EMDN description: FOLATE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

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Gastrin-17 Chemiluminescence Immunoassay Test Kit

G210A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802370
Basic UDI-DI: B-06952804802370
Reference: G210A08
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

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Alpha Fetoprotein Chemiluminescence Immunoassay Test Kit

G200A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802363
Basic UDI-DI: B-06952804802363
Reference: G200A08
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

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Adenovirus Respiratory Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804800697
Basic UDI-DI: B-06952804800697
Reference: /
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Antigen Rapid Test

A49930125, A49930225

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804800680
Basic UDI-DI: 69528048A4993004H
Reference: A49930
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Strip, Device, Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804800550
Basic UDI-DI: B-06952804800550
Reference: /
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details