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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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17.07.2026 01:19

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Active filter:Manufacturer SRN:CN-MF-000033566

63 device results listed.

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LYHER

303021901

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611515
Basic UDI-DI: 0697241261IRS-542BF
Reference: 303021901
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303034701-01;303034701-05;303034701-20;303034701-25;303034701-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611492
Basic UDI-DI: 0697241261IRS-552BJ
Reference: 303034701-20
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

06972412611478

303041901

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611478
Basic UDI-DI: 0697241261IRS-572BQ
Reference: 303041901
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 01:14

Manufacturer products Authorised representative products Authorised representative actors View details

06972412618057

Respiratory Multiple Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618057
Basic UDI-DI: B-06972412618057
Reference: 303021901
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

06972412616237

Malaria Antigen Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412616237
Basic UDI-DI: B-06972412616237
Reference: 303038501, 303036501
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

06972412612031

303050

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612031
Basic UDI-DI: B-06972412612031
Reference: 303050
EMDN: W010106020301
EMDN description: URINE SEDIMENTTEST KIT (MANUAL)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

06972412612024

303034

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612024
Basic UDI-DI: B-06972412612024
Reference: 303034
EMDN: W010106020301
EMDN description: URINE SEDIMENTTEST KIT (MANUAL)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

06972412612017

303035

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612017
Basic UDI-DI: B-06972412612017
Reference: 303035
EMDN: W010106020301
EMDN description: URINE SEDIMENTTEST KIT (MANUAL)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

06972412611874

NovelCoronavirus (COVID-19)AntigenTest Kit(ColloidalGold)for self-testing

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611874
Basic UDI-DI: B-06972412611874
Reference: 303036-05
EMDN: W0105040519
EMDN description: CORONAVIRUS - NA REAGENTS
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

303051

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611256
Basic UDI-DI: B-06972412611256
Reference: 303051
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412617937
Basic UDI-DI: 0697241261IRS-552BJ
Reference: 303034701-01
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 03.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618354
Basic UDI-DI: 0697241261IRS-552BJ
Reference: 303034701-05
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 03.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611508
Basic UDI-DI: 0697241261IRS-552BJ
Reference: 303034701-25
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 03.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412618880
Basic UDI-DI: 0697241261IRS-552BJ
Reference: 303034701-40
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 03.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IDE-A402-01; IDE-A402-05; IDE-A402-20; IDE-A402-25; IDE-A402-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412613991
Basic UDI-DI: 697241261IDE-A402EJ
Reference: IDE-A402-25
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IAD-502-01; IAD-502-05; IAD-502-20; IAD-502-25; IAD-502-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612376
Basic UDI-DI: 697241261IAD-5026X
Reference: IAD-502-05
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

06972412611997

BIOSYNEX FLACON URINE URITOP +2

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611997
Basic UDI-DI: 697241261860693RJ
Reference: 860693
EMDN: A99
EMDN description: DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER
First on market country: France
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

IHMP-502-01;IHMP-502-05; IHMP-502-20; IHMP-502-25; IHMP-502-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611737
Basic UDI-DI: 697241261IHMP-502TL
Reference: IHMP-502-25
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

ICO-502-01; ICO-502-05; ICO-502-20; ICO-502-25; ICO-502-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412610716
Basic UDI-DI: 697241261ICO-502BJ
Reference: ICO-502-25
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 02.07.2026 12:54

Manufacturer products Authorised representative products Authorised representative actors View details

LYHER

ISY-401-01;ISY-401-05; ISY-401-20; ISY-401-25; ISY-401-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412619481
Basic UDI-DI: 697241261ISY-401M9
Reference: ISY-401-01
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:03

Manufacturer products Authorised representative products Authorised representative actors View details