Public EUDAMED Search

EUDAMED Device Search

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

TR EN

Last updated

24.09.2026 20:13

Sync status

Successful

Device

3611017

Actor

47888

Certificate

3409

Filters

Show filters

Active filter:EMDN:W

1000+ device results listed.

Page 25 / 50

CSV XML

Dry immunoassay analyzer

Please see UDI-DI for detail

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Guangzhou KOFA Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045346
UDI-DI: 06974576207672
Basic UDI-DI: 697457620SSDiaXY
Reference: 1FF00006
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Romania
Authorised representative: Medunion S.L.
Last updated: 24.09.2026 14:13

Manufacturer products Authorised representative products Authorised representative actors View details

PreventID® CalScreen®

PreventID® CalScreen

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598009059
Basic UDI-DI: B-04050598009059
Reference: KST11004TP
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 14:05

Manufacturer products View details

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015197
Basic UDI-DI: B-04050598015197
Reference: KSTDE001GP.01
EMDN: W0105060399
EMDN description: MYCOLOGY IMMUNOASSAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 14:05

Manufacturer products View details

HPV Genotyping Real-Time PCR Kit (Fluorescent PCR)

BSJ01M1， BSJ01L1

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
Manufacturer SRN: CN-MF-000019512
UDI-DI: 06973843227795
Basic UDI-DI: 697384322BSJ01JA
Reference: BSJ01L1
EMDN: W0105041004
EMDN description: FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.09.2026 14:04

Manufacturer products Authorised representative products Authorised representative actors View details

06973685471387

64Tests/kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: 3D Biomedicine Science & Technology Co., Limited
Manufacturer SRN: CN-MF-000020934
UDI-DI: 06973685471387
Basic UDI-DI: 697368547138Q7
Reference: 3000000000449
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 24.09.2026 14:03

Manufacturer products Authorised representative products Authorised representative actors View details

06973685471356

96A Automated Viral DNA/RNA Isolation Kit

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: 3D Biomedicine Science & Technology Co., Limited
Manufacturer SRN: CN-MF-000020934
UDI-DI: 06973685471356
Basic UDI-DI: 697368547135PZ
Reference: 3000000000012
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 24.09.2026 14:03

Manufacturer products Authorised representative products Authorised representative actors View details

06973685471325

64Test/Kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: 3D Biomedicine Science & Technology Co., Limited
Manufacturer SRN: CN-MF-000020934
UDI-DI: 06973685471325
Basic UDI-DI: 697368547132PT
Reference: 3000000000435
EMDN: W0105900101
EMDN description: REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS
First on market country: Italy
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 24.09.2026 14:03

Manufacturer products Authorised representative products Authorised representative actors View details

PreventID® Dermatophyte

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598010284
Basic UDI-DI: B-04050598010284
Reference: KSTDE001GP
EMDN: W0105060399
EMDN description: MYCOLOGY IMMUNOASSAYS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 14:02

Manufacturer products View details

Automatic Dry Fluorescent Immunoassay Analyzer

FIC-H1W、FIC-H1N、FIC-Q100、FIC-Q100N、FIC-H2、FIC-S100、FIC-A1600、FIC-M6、FIC-M6G、FIC-H0、FIC-H0mini、FIC-M2、FIC-M2NT

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Suzhou Helmen Precision Insturments Co.,Ltd
Manufacturer SRN: CN-MF-000002230
UDI-DI: 06973602151514
Basic UDI-DI: 697360215FICNY
Reference: FIC-FA120P
EMDN: W0201020101
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.09.2026 14:02

Manufacturer products Authorised representative products Authorised representative actors View details

PreventID® Ovulation

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598013285
Basic UDI-DI: B-04050598013285
Reference: KST12110G7
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: -
Last updated: 24.09.2026 14:02

Manufacturer products View details

06941967243809

Adenosine Deaminase (ADA) Kit (Enzymatic Method)

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967243809
Basic UDI-DI: 697326286002832H
Reference: 0103015
EMDN: W0102019010
EMDN description: ADENOSINE DEAMINASE
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 14:01

Manufacturer products Authorised representative products Authorised representative actors View details

06941967243786

Rheumatoid Factor (RF) Kit (Latex Enhanced Immunoturbidimetric Method)

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

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967243786
Basic UDI-DI: 6973262860030726
Reference: 0106616
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 14:01

Manufacturer products Authorised representative products Authorised representative actors View details

06941967243656

TH-SP-Diluent

IVD Class AIVDR 2017/746On the marketKitReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967243656
Basic UDI-DI: 697326286002822F
Reference: 1301603
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 14:01

Manufacturer products Authorised representative products Authorised representative actors View details

06941967242727

Coagulation Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242727
Basic UDI-DI: 697326286002662H
Reference: 1301313
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 14:01

Manufacturer products Authorised representative products Authorised representative actors View details

06941967242703

Fibrin/fibrinogen Degradation Products (FDP) Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242703
Basic UDI-DI: 697326286002652F
Reference: 1301311
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 14:01

Manufacturer products Authorised representative products Authorised representative actors View details

06941967242680

D-Dimer Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242680
Basic UDI-DI: 697326286002642D
Reference: 1301309
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 24.09.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details

06941967237129

H58 LS

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967237129
Basic UDI-DI: 69732628600131ZN
Reference: 0401060
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 24.09.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details

06941967237082

H58 LD

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967237082
Basic UDI-DI: 69732628600130ZL
Reference: 0401052
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 24.09.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details

06941967237006

H58 LN

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967237006
Basic UDI-DI: 6973262860012824
Reference: 0401056
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Austria
Authorised representative: Lotus NL B.V.
Last updated: 24.09.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details

06941967227175

EXI 2400, EXI 2420

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967227175
Basic UDI-DI: 69732628600141ZR
Reference: 0601001
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.09.2026 14:00

Manufacturer products Authorised representative products Authorised representative actors View details