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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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20.08.2026 09:24

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Active filter:Manufacturer SRN:CN-MF-000003349

244 device results listed.

Page 1 / 13

Glycosylated Hemoglobin A1c Assay (Immunofluorescence)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967218319
Basic UDI-DI: B-06941967218319
Reference: 2013501
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 02:15

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Assay (Immunofluorescence) (

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262863345
Basic UDI-DI: B-06973262863345
Reference: 2013001
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein Assay (Immunofluorescence)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262863260
Basic UDI-DI: B-06973262863260
Reference: 2012501
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

TSH Assay (Immunofluorescence)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967221784
Basic UDI-DI: B-06941967221784
Reference: 2013801
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Assay (Immunofluorescence)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967221739
Basic UDI-DI: B-06941967221739
Reference: 2013101
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

T4 Assay (Immunofluorescence)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967221296
Basic UDI-DI: B-06941967221296
Reference: 2013701
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

T3 Assay (Immunofluorescence)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967221210
Basic UDI-DI: B-06941967221210
Reference: 2013601
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

Interleukin-6 Assay (Immunofluorescence)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967219200
Basic UDI-DI: B-06941967219200
Reference: 2013901
EMDN: W01030609
EMDN description: INTERLEUKIN 6 (IL-6)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

Protein and peptide extraction kit (Magnetic Beads Method)

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242185
Basic UDI-DI: 697326286002882T
Reference: 0502203
EMDN: W010499
EMDN description: MICROBIOLOGY TESTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.08.2026 16:19

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242192
Basic UDI-DI: 697326286002882T
Reference: 0502204
EMDN: W010499
EMDN description: MICROBIOLOGY TESTS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 04.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

EXM 3000 Duo

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967242239
Basic UDI-DI: 697326286002672K
Reference: 0307402
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

ResinAerobicBottle(AE)；PediatricResinBottle(PE)

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967236627
Basic UDI-DI: 69732628600118ZW
Reference: 0501203
EMDN: W0104010504
EMDN description: BOTTLES FOR AUTOMATED BLOOD CULTURE
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

Resin Anaerobic Bottle (AN)

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967236351
Basic UDI-DI: 69732628600117ZU
Reference: 0501201
EMDN: W0104010504
EMDN description: BOTTLES FOR AUTOMATED BLOOD CULTURE
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

EXB 120, EXB 120S, EXB 120P, EXB60-Lite, EXB60-Vita, EXB60-Nova

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967235996
Basic UDI-DI: 69732628600112ZJ
Reference: 0501101
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967236009
Basic UDI-DI: 69732628600112ZJ
Reference: 0501102
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967236016
Basic UDI-DI: 69732628600112ZJ
Reference: 0501103
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967243953
Basic UDI-DI: 69732628600112ZJ
Reference: 0502402
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967243977
Basic UDI-DI: 69732628600112ZJ
Reference: 0502406
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967243960
Basic UDI-DI: 69732628600112ZJ
Reference: 0502404
EMDN: W02030201
EMDN description: AUTOMATED BLOOD CULTURE ANALYSERS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967236634
Basic UDI-DI: 69732628600118ZW
Reference: 0501204
EMDN: W0104010504
EMDN description: BOTTLES FOR AUTOMATED BLOOD CULTURE
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details