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335 device results listed.

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06952804825713

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

06952804824273

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

06952804817879

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

16952804801615

IVD generalNot specifiedOn the market

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 16952804801615
Basic UDI-DI: B-16952804801615
Reference: MD-U6160
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

Fastep

IVD self-testing devicesNot specifiedOn the market

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 16952804833715
Basic UDI-DI: B-16952804833715
Reference: MI-S33001H5
EMDN: -
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

06952804825645

IVD Class ANot specifiedOn the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804825645
Basic UDI-DI: 69528048CLI1000XN4
Reference: CLI1000X
EMDN: -
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 29.06.2026 23:00

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

Blood Glucose and β-Ketone Test Meter

GKE-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804834982
Basic UDI-DI: 69528048C9040002X
Reference: 69528048C9040002X
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

Blood Glucose and Uric Acid Test Meter

GUE-101

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804834975
Basic UDI-DI: 69528048C9030002Q
Reference: GUE-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 12:34

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: 06952804834968
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 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood Buffer

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804833503
Basic UDI-DI: 69528048FOB-B001NL
Reference: FOB-B001
EMDN: W0105900201
EMDN description: BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin Combo Rapid Test (20/20mIU)

Format(Strip):A02600150, A02600250;Format(Device):A03010125, A03010140, A03010225, A03010240

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804833459
Basic UDI-DI: 69528048A030100WF
Reference: Format(Strip):A02600;Format(Device):A03010
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details