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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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220 device results listed.

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06941967224600

H56 LD-II

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224600
Basic UDI-DI: 697326286000592A
Reference: 01.09.31.03.03.02
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224594

H56 LD-I

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224594
Basic UDI-DI: 6973262860005828
Reference: 01.09.31.03.02.02
EMDN: W01030199
EMDN description: HAEMATOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224556

Check-P

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224556
Basic UDI-DI: 6973262860006525
Reference: 01.09.31.01.Q.32
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224532

Cal-P

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224532
Basic UDI-DI: 6973262860006423
Reference: 01.09.31.00.01.03
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224501

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224501
Basic UDI-DI: 69732628600060ZQ
Reference: 01.09.31.03.01.03
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224471

SR-I

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224471
Basic UDI-DI: 69732628600063ZW
Reference: 01.09.30.01.01.04
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224440

CR-I

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224440
Basic UDI-DI: 69732628600062ZU
Reference: 01.09.30.00.Z.25
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967217626

Wash Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967217626
Basic UDI-DI: 69732628600045ZU
Reference: 01.09.1F.01.13.11
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967217619

Cleanser

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967217619
Basic UDI-DI: 69732628600044ZS
Reference: 01.09.1F.01.13.23
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967217596

Urinalysis Diluent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967217596
Basic UDI-DI: 69732628600043ZQ
Reference: 01.09.1F.01.12.05
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967217572

Sheath Fluid

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967217572
Basic UDI-DI: 69732628600042ZN
Reference: 01.09.1F.01.11.12
EMDN: W01010999
EMDN description: MULTIPLE PARAMETERS URINE TESTING - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

Z50

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967213123
Basic UDI-DI: 69732628630301*********ZR
Reference: 3030102
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967205678

EXC400, EXC420

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967205678
Basic UDI-DI: 69732628600037ZV
Reference: 02-10-00-0005-00
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Quantitative Real-time PCR System

EXP 960, EXP 961, EXP 962, EXP 963

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967205173
Basic UDI-DI: 697326286000792G
Reference: 02-17-01-0021-00
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967200932

EXZ 6000

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200932
Basic UDI-DI: 69732628600061ZS
Reference: 02-13-01-0004-00
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967200895

EXZ 6000Pro, EXZ 6010Pro, EXZ 6020Pro

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200895
Basic UDI-DI: 6973262860003924
Reference: 02-13-04-0010-00
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Fluorescence Immunochromatography Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200185
Basic UDI-DI: 69732628600036ZT
Reference: 02-11-03-0001-00
EMDN: W0201020201
EMDN description: IMMUNOCHEMISTRY READERS
First on market country: Northern Ireland
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967242291

IVD Class ANot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242291
Basic UDI-DI: 6973262860014626
Reference: 0112805
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: 25.06.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

06941967231509

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967231509
Basic UDI-DI: B-06941967231509
Reference: 0603901
EMDN: W0102030111
EMDN description: CYFRA 21-1
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details

06941967231486

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967231486
Basic UDI-DI: B-06941967231486
Reference: 0603801
EMDN: W0102030119
EMDN description: HUMAN EPIDIDYMIS PROTEIN 4
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:51

Manufacturer products Authorised representative products Authorised representative actors View details