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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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338 device results listed.

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NT-ProBNP Chemiluminescence Immunoassay Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825867
Basic UDI-DI: B-06952804825867
Reference: G112A08X
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin Chemiluminescence Immunoassay Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825850
Basic UDI-DI: B-06952804825850
Reference: G105A08X
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

High-sensitive Cardiac Troponin I Chemiluminescence Immunoassay Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825843
Basic UDI-DI: B-06952804825843
Reference: G104A08X
EMDN: W0102160799
EMDN description: CARDIAC MARKERS - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

MB Isoenzyme of Creatine Kinase Chemiluminescence Immunoassay Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825836
Basic UDI-DI: B-06952804825836
Reference: G106A08X
EMDN: W0102160702
EMDN description: MYOGLOBIN - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Free Thyroid Hormone Chemiluminescence Immunoassay Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825775
Basic UDI-DI: B-06952804825775
Reference: G016A08X
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Free Triiodothyronine Chemiluminescence Immunoassay Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825768
Basic UDI-DI: B-06952804825768
Reference: G015A08X
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid Hormone Chemiluminescence Immunoassay Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825751
Basic UDI-DI: B-06952804825751
Reference: G012A08X
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Triiodothyronine Chemiluminescence Immunoassay Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825744
Basic UDI-DI: B-06952804825744
Reference: G017A08X
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid Stimulating Hormone Chemiluminescence Immunoassay Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825713
Basic UDI-DI: B-06952804825713
Reference: G019A08X
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Strips

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804824273
Basic UDI-DI: B-06952804824273
Reference: C902005
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Total Cholesterol Test Strips

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817879
Basic UDI-DI: B-06952804817879
Reference: C906005
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 11:32

Manufacturer products Authorised representative products Authorised representative actors View details

Lactate Test Meter

LAC-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804835088
Basic UDI-DI: 69528048LAC-101FF
Reference: LAC-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 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

G6PD and Hemoglobin Biosensor Test Meter

GPHB-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804835071
Basic UDI-DI: 69528048GPHB-101UT
Reference: GPHB-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 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Saliva Collection System

CS-S01，CS-S02

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804835064
Basic UDI-DI: 69528048CS-S01MK
Reference: CS-S01，CS-S02
EMDN: W05019002
EMDN description: SALIVA COLLECTION DEVICES
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Colloidal Immunoassay Analyzer

ADT100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804835057
Basic UDI-DI: 69528048ADT100JP
Reference: ADT100
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 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunoassay Analyzer

TFL1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804835040
Basic UDI-DI: 69528048TFL1000RG
Reference: TFL1000
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 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Blood Glucose Test Meter

GOH-101Pro

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804835033
Basic UDI-DI: 69528048GOH-101ProH4
Reference: GOH-101Pro
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 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Colloidal Gold Test Analyzer

ACG1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804835019
Basic UDI-DI: 69528048ACG10000CV
Reference: ACG1000
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 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Portable Glycosylated Hemoglobin Analyzer

HbA1c-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804835002
Basic UDI-DI: 69528048HbA1C-1018B
Reference: HbA1c-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 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Fully Automatic Biochemistry Analyzer

AS-60C

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804834999
Basic UDI-DI: 69528048JB00F00CB
Reference: AS-60C
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 12:34

Manufacturer products Authorised representative products Authorised representative actors View details