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335 device results listed.

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Respiratory Syncytial Virus Antigen Rapid Test

A46210120, A46210220

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804811112
Basic UDI-DI: 69528048A462100ZJ
Reference: A46210
EMDN: W0105040605
EMDN description: RESPIRATORY SYNCYTIAL VIRUS (RSV)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Handheld DOA Reader

ADT 2000

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804811105
Basic UDI-DI: 695280480857K9
Reference: ADT2000
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Ethylglucuronide (ETG) Rapid Test Device (Urine)

Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804810948
Basic UDI-DI: B-06952804810948
Reference: ETG-U23
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Cardiac Troponin I Rapid Test Device (Whole Blood/Serum/Plasma)

Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804810788
Basic UDI-DI: B-06952804810788
Reference: TRO-W23
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)

Device

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804810726
Basic UDI-DI: B-06952804810726
Reference: HIV-W23
EMDN: W0105090302
EMDN description: HIV 1 / 2 - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Tuberculosis Rapid Test Device (Whole Blood/Serum/Plasma)

Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804810672
Basic UDI-DI: B-06952804810672
Reference: TB-W23
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antigen Rapid Test

A4A412125,A4A412225

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804810641
Basic UDI-DI: 69528048A4A41205P
Reference: A4A412
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

06952804809850

Adenovirus Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle useSterile

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804809850
Basic UDI-DI: B-06952804809850
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 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Device

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: 06952804809720
Basic UDI-DI: 69528048A463101ZT
Reference: A46310120
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

Respiratory Syncytial Virus Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804809508
Basic UDI-DI: B-06952804809508
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 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Rapid Test Device

A46071120,A46071220

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804809478
Basic UDI-DI: 69528048A46071028
Reference: A46071
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

06952804809072

Multi-drug Saliva Test Cup

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804809072
Basic UDI-DI: B-06952804809072
Reference: MD-S42~MD-W415
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 & Influenza A/B Antigen Nasal Test Kit

1 pcs/kit

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804808976
Basic UDI-DI: B-06952804808976
Reference: MI-S33001H
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

AFI 6100B

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804808457
Basic UDI-DI: 695280480845K2
Reference: AFI 6100B
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

06952804808341

Multi-drug Urine Test Cup

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804808341
Basic UDI-DI: B-06952804808341
Reference: MD-U6155
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Nasal Test Kit

COV-S35002H

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804808150
Basic UDI-DI: B-06952804808150
Reference: COV-S35002H
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Saliva Test Kit

kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804807511
Basic UDI-DI: B-06952804807511
Reference: COV-S35
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Saliva Test Kit

kit 3pcs/box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804807450
Basic UDI-DI: B-06952804807450
Reference: COV-S35
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2 Antigen Rapid Tests for Self-Testing

Device 1 person/box

IVD self-testing devicesIVDDOn the marketKitNear-patient testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804807276
Basic UDI-DI: B-06952804807276
Reference: COV-S23004H/COV-S23006H
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test Device

Device 1 person/box

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804807238
Basic UDI-DI: B-06952804807238
Reference: COV-S23
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details