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335 device results listed.

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Human Chorionic Gonadotropin Combo Rapid Test

HCG-C11 HCG-C23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804813864
Basic UDI-DI: B-06952804813864
Reference: HCG-C11 HCG-C23
EMDN: W0102160302
EMDN description: HCG - RT & POC
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

Human Chorionic Gonadotropin Rapid Test

HCG-U11, HCG-U23, HCG-U35

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804813734
Basic UDI-DI: B-06952804813734
Reference: HCG-U11 HCG-U23 HCG-U35
EMDN: W0102160302
EMDN description: HCG - RT & POC
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

Blood Cholesterol Monitoring Systems (Blood Cholesterol Meter, Test Strip)

CML-101,MLS-101

IVD self-testing devicesIVDDOn the marketInstrumentKitSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804813697
Basic UDI-DI: B-06952804813697
Reference: CML-101,MLS-101
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

Hemoglobin Test Strips and Hemoglobin Meter

AS-XH-02,HBM-W11

IVD generalIVDDOn the marketInstrumentKitProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804813673
Basic UDI-DI: B-06952804813673
Reference: AS-XH-02, HBM-W11
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
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

Semi-Automatic Fluorescence Immunassay Analyzer

AFI 5300

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804813338
Basic UDI-DI: 69528048KB03100AD
Reference: AFI 5300
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

Blood Glucose and Uric Acid and Total Cholesterol Test Meter

GUC-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804813178
Basic UDI-DI: 69528048C913F006C
Reference: GUC-101
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

Handheld DOA Reader

ADT3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804813109
Basic UDI-DI: 69528048AB03F0087
Reference: ADT3000
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

Multi-functional Monitor

MSE-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804813031
Basic UDI-DI: 69528048D9000002L
Reference: MSE-101
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

Blood Glucose and Hemoglobin Test Meter

GHE-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804812966
Basic UDI-DI: 69528048C90500036
Reference: GHE-101
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

Uric Acid Test Strips

C903005

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804812577
Basic UDI-DI: B-06952804812577
Reference: C903005
EMDN: W01010232
EMDN description: URIC ACID
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

Blood Glucose Test Strips

C901005

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804812553
Basic UDI-DI: B-06952804812553
Reference: C901005
EMDN: W0201060102
EMDN description: BLOOD GLUCOSE METERS
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

Automatic Chemiluminesence Immunoanalyzer

CLI1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804812478
Basic UDI-DI: 69528048GB01F00AX
Reference: CLI1000
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

06952804811532

Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804811532
Basic UDI-DI: B-06952804811532
Reference: MDMA-W23, MDMA-U11
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - 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

Zolpidem ZOL Rapid Test Device (Urine)

Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804811358
Basic UDI-DI: B-06952804811358
Reference: ZOL-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

HBHP (FOB + HBHP)

Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804811181
Basic UDI-DI: B-06952804811181
Reference: MT-F43M002
EMDN: W0101060301
EMDN description: GUAIAC-BASED FECAL FAECAL OCCULT BLOOD (CC)
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

S. pneumoniae Rapid Test Device (Urine)

Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804811174
Basic UDI-DI: B-06952804811174
Reference: SPN-U23
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:27

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella Antigen Rapid Test Device (Urine)

Device

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804811167
Basic UDI-DI: B-06952804811167
Reference: LEG-U23
EMDN: W0105090108
EMDN description: LEGIONELLA - 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

Norovirus GI+GII Rapid Test

Format (cassette): A4B27111 A4B271125 A4B271140 A4B27121 A4B271225 A4B271240

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804811129
Basic UDI-DI: 69528048A4B27106F
Reference: A4B271
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
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

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