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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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408 device results listed.

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COVID-19 Antigen FIA

COV-S23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802905
Basic UDI-DI: B-06952804802905
Reference: COV-S23F3
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

STA FIA

STA-S23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802899
Basic UDI-DI: B-06952804802899
Reference: STA-S23F3
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

ADV FIA

ADV-S23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802882
Basic UDI-DI: B-06952804802882
Reference: ADV-S23F3
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

RSV FIA

RSV-S23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802875
Basic UDI-DI: B-06952804802875
Reference: RSV-S23F3
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

FLU A/B FIA

FLU-S23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802868
Basic UDI-DI: B-06952804802868
Reference: FLU-S23F3
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

AFP FIA

AFP-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802844
Basic UDI-DI: B-06952804802844
Reference: AFP-W23F3
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

CRP FIA

CRP-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802837
Basic UDI-DI: B-06952804802837
Reference: CRP-W23F3
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

PCT FIA

PCT-W23F3

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802820
Basic UDI-DI: B-06952804802820
Reference: PCT-W23F3
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-Dimer FIA

DDM-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802813
Basic UDI-DI: B-06952804802813
Reference: DDM-W23F3
EMDN: W0103020803
EMDN description: D-DIMER - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

CKMB FIA

CKMB-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802806
Basic UDI-DI: B-06952804802806
Reference: CKMB-W23F3
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

TRO-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802790
Basic UDI-DI: B-06952804802790
Reference: TRO-W23F3
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

NT-ProBNP FIA

BNP -W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802783
Basic UDI-DI: B-06952804802783
Reference: BNP -W23F3
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c FIA

HbA1c-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802776
Basic UDI-DI: B-06952804802776
Reference: HbA1c-W23F3
EMDN: W0101060107
EMDN description: HBA1C TEST STRIPS
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

Heart Fatty Acid Bindingprotein Chemiluminescence Immunoassay Test Kit

G103A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802479
Basic UDI-DI: B-06952804802479
Reference: G103A08
EMDN: W0102160705
EMDN description: HEART-TYPE FATTY ACID-BINDING PROTEIN - 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

β2-microglobulin Chemiluminescence Immunoassay Test Kit

G217A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802462
Basic UDI-DI: B-06952804802462
Reference: G217A08
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
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

Squamous Cell Carcinoma Antigen Chemiluminescence Immunoassay Test Kit

G216A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802455
Basic UDI-DI: B-06952804802455
Reference: G216A08
EMDN: W0102030116
EMDN description: SQUAMOUS CELL CARCINOMA ANTIGEN
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

Carcinoembryonic Antigen Chemiluminescence Immunoassay Test Kit

G207A08

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802448
Basic UDI-DI: B-06952804802448
Reference: G207A08
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
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

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

Manufacturer products Authorised representative products Authorised representative actors View details