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

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Active filter:Manufacturer SRN:CN-MF-000003349

220 device results listed.

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06941967216131

11FU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967216131
Basic UDI-DI: B-06941967216131
Reference: 01.09.1F.01.01.04
EMDN: W01010901
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

06941967216124

12FU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967216124
Basic UDI-DI: B-06941967216124
Reference: 01.09.1F.01.01.05
EMDN: W01010901
EMDN description: URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 16.07.2026 18:45

Manufacturer products Authorised representative products Authorised representative actors View details

06941967218951

US-Calibrator

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967218951
Basic UDI-DI: 697326286001982R
Reference: 01.09.1F.01.10.05
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Poland
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

06941967218968

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967218968
Basic UDI-DI: 697326286001982R
Reference: 01.09.1F.01.10.04
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

06973262868111

Glucose (GLU) Kit (Hexokinase Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262868111
Basic UDI-DI: B-06973262868111
Reference: 1080202
EMDN: W01010213
EMDN description: GLUCOSE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 16:56

Manufacturer products Authorised representative products Authorised representative actors View details

06973262865837

Creatine Kinase (CK) Kit (Rate Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262865837
Basic UDI-DI: B-06973262865837
Reference: 01.09.04.03.EC.01
EMDN: W01010113
EMDN description: CREATINE KINASE - TOTAL
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 16:56

Manufacturer products Authorised representative products Authorised representative actors View details

06973262869149

Sample Pretreatment Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262869149
Basic UDI-DI: 69732628600032ZK
Reference: 01.09.63.02.01.05
EMDN: W010499
EMDN description: MICROBIOLOGY TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:28

Manufacturer products Authorised representative products Authorised representative actors View details

06973262869071

Blood Culture Positive Sample Pretreatment Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262869071
Basic UDI-DI: 69732628600031ZH
Reference: 01.09.62.01.01.10
EMDN: W010499
EMDN description: MICROBIOLOGY TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262868982

Microbe Sample Pretreatment Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262868982
Basic UDI-DI: 69732628600030ZF
Reference: 01.09.61.01.01.13
EMDN: W010499
EMDN description: MICROBIOLOGY TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262868920

Mold Sample Pretreatment Kit

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262868920
Basic UDI-DI: 69732628600029ZW
Reference: 01.09.64.01.01.08
EMDN: W010499
EMDN description: MICROBIOLOGY TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262868791

Sample Treatment Matrix Solution

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262868791
Basic UDI-DI: 69732628600028ZU
Reference: 01.09.63.01.01.14
EMDN: W010499
EMDN description: MICROBIOLOGY TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262866131

EXI 1800, EXI 1810, EXI 1820, EXI 1830

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262866131
Basic UDI-DI: 69732628600007ZL
Reference: 02-12-02-0004-00
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: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262866124

ZIP-96V

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262866124
Basic UDI-DI: 69732628600001Z8
Reference: 02-17-01-0012-00
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 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262866117

Q8 Pro

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262866117
Basic UDI-DI: 69732628600006ZJ
Reference: 02-11-01-0001-00
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: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262866001

EXM6000, EXM6200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262866001
Basic UDI-DI: 69732628600005ZG
Reference: 02-14-02-0013-00
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 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262865554

EXM3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262865554
Basic UDI-DI: 69732628600004ZE
Reference: 02-14-01-0013-00
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 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262865332

Z5 DN

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262865332
Basic UDI-DI: 69732628600011ZB
Reference: 01.09.31.04.Z5.03
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262865301

Lyse

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262865301
Basic UDI-DI: 69732628600009ZQ
Reference: 01.09.31.03.Z3.02
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262865295

01.09.31.02.Z3.05

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262865295
Basic UDI-DI: 69732628600008ZN
Reference: 01.09.31.02.Z3.05
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06973262864403

EXP 160R, EXP 161R

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262864403
Basic UDI-DI: 69732628600003ZC
Reference: 02-17-01-0004-00
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 14:27

Manufacturer products Authorised representative products Authorised representative actors View details