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EUDAMED Device Search

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C Reactive Protein (CRP) (Latex)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458514003EK
Basic UDI-DI: B-G458514003EK
Reference: 514 003
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 22.09.2026 03:06

Manufacturer products Authorised representative products Authorised representative actors View details

06976612386006

1gE 1 test/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jinan Deheng Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000048173
UDI-DI: 06976612386006
Basic UDI-DI: B-06976612386006
Reference: IgE 1 test/kit
EMDN: W01020201
EMDN description: IMMUNOGLOBULIN E - TOTAL
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 22.09.2026 02:59

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Drug 10 Drugs Test Cassette(Oral Fluid)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06942598223789
Basic UDI-DI: B-06942598223789
Reference: DSD-8105-A
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:57

Manufacturer products Authorised representative products Authorised representative actors View details

BlueDiver Quantrix ANA25 Screen IgG

BlueDiver Quantrix

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023682005
Basic UDI-DI: 542502368BDQANA3C
Reference: ANA25Q-24
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 22.09.2026 02:57

Manufacturer products View details

ARCHITECT

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740175634
Basic UDI-DI: 038074ARP0632PM
Reference: 06P3210
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:51

Manufacturer products View details

ARCHITECT

ARCHITECT NSE

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740175641
Basic UDI-DI: 038074ARP0632PM
Reference: 06P3225
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 02:51

Manufacturer products View details

IDK® ß-Glucuronidase Aktivität

IDK® beta-Glucuronidase Aktivität

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598009264
Basic UDI-DI: B-04050598009264
Reference: K 6991
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 02:46

Manufacturer products View details

LyoSens™

VDDOA20

IVD Class BIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548251688
Basic UDI-DI: 868499827PCR02XD
Reference: LYO02WS48
EMDN: W0102160502
EMDN description: AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 02:45

Manufacturer products View details

CEA Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-TCE-R402EW
Basic UDI-DI: B-TCE-R402EW
Reference: TCE-R402
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 22.09.2026 02:44

Manufacturer products Authorised representative products Authorised representative actors View details

FOB Rapid Test (Faeces)

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983125765
Basic UDI-DI: B-06936983125765
Reference: TFO-601H
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:43

Manufacturer products Authorised representative products Authorised representative actors View details

06936983155229

CA125 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983155229
Basic UDI-DI: B-06936983155229
Reference: T125-402
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:42

Manufacturer products Authorised representative products Authorised representative actors View details

06936983155212

CA15-3 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983155212
Basic UDI-DI: B-06936983155212
Reference: T153-402
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:42

Manufacturer products Authorised representative products Authorised representative actors View details

06936983123099

CA19-9 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983123099
Basic UDI-DI: B-06936983123099
Reference: T199-402
EMDN: W0102030103
EMDN description: CANCER ANTIGEN 19-9
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:42

Manufacturer products Authorised representative products Authorised representative actors View details

KEYU Giardia lamblia Antigen Test Kit (Colloidal Gold Method)

GL-I

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Keyu Biological Engineering Co., Ltd
Manufacturer SRN: CN-MF-000023195
UDI-DI: 06974735361849
Basic UDI-DI: B-06974735361849
Reference: GL-I
EMDN: W01021699
EMDN description: RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

Easy @ Home® Pregnancy Test

EZW1-S-20

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-EZW1-S-20CD
Basic UDI-DI: B-EZW1-S-20CD
Reference: EZW1-S-20
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.09.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-CPC-R302AR

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CPC-R302AR
Basic UDI-DI: B-CPC-R302AR
Reference: CPC-R302
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 02:27

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Vasculitis - 1 Pack

Aptiva® Vasculitis Kits Pack - 1

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126001069
Basic UDI-DI: 0195126001069PU
Reference: 722103
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.09.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Vasculitis - 3 Pack

Aptiva® Vasculitis Kits Pack - 1

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126001076
Basic UDI-DI: 0195126001069PU
Reference: 722104
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.09.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Vasculitis - 5 Pack

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 00195126001083
Basic UDI-DI: 0195126001069PU
Reference: 722105
EMDN: W0102100403
EMDN description: PR3 ANCA
First on market country: -
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 22.09.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-CRP-402SX
Basic UDI-DI: B-FI-CRP-402SX
Reference: FI-CRP-402
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.09.2026 01:56

Manufacturer products Authorised representative products Authorised representative actors View details