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EUDAMED Device Search

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

Last updated

05.07.2026 19:04

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63 device results listed.

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IDE-425-01; IDE-425-05; IDE-425-20; IDE-425-25; IDE-425-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412614523
Basic UDI-DI: 697241261IDE-4258Q
Reference: IDE-425-01
EMDN: W0105099007
EMDN description: DENGUE - 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

ISY-402-01; ISY-402-05; ISY-402-20; ISY-402-25; ISY-402-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412613984
Basic UDI-DI: 697241261ISY-402MB
Reference: ISY-402-20
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

IDE-B402-01; IDE-B402-05; IDE-B402-20; IDE-B402-25; IDE-B402-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412613977
Basic UDI-DI: 697241261IDE-B402ER
Reference: IDE-B402-01
EMDN: W0105099007
EMDN description: DENGUE - 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

ISY-402-01; ISY-402-05; ISY-402-20; ISY-402-25; ISY-402-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412613311
Basic UDI-DI: 697241261ISY-402MB
Reference: ISY-402-40
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

ISY-402-01; ISY-402-05; ISY-402-20; ISY-402-25; ISY-402-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612895
Basic UDI-DI: 697241261ISY-402MB
Reference: ISY-402-05
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

IDE-B402-01; IDE-B402-05; IDE-B402-20; IDE-B402-25; IDE-B402-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612789
Basic UDI-DI: 697241261IDE-B402ER
Reference: IDE-B402-40
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

ISY-402-01; ISY-402-05; ISY-402-20; ISY-402-25; ISY-402-40

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612536
Basic UDI-DI: 697241261ISY-402MB
Reference: ISY-402-25
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06972412612413
Basic UDI-DI: 697241261ISY-401M9
Reference: ISY-401-25
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

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: 06972412612260
Basic UDI-DI: 697241261ISY-401M9
Reference: ISY-401-20
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

Cassette

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611799
Basic UDI-DI: 697241261IGC-5259E
Reference: IGC-525
EMDN: W0105070501
EMDN description: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS
First on market country: Finland
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

Cassette

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611782
Basic UDI-DI: 697241261IGO-502D6
Reference: IGO-502
EMDN: W0105010201
EMDN description: GONOCOCCAL ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

Chlamydia Antigen Rapid Test Kit

Cassette

IVD Class CIVDR 2017/746On the marketCompanion diagnosticsProfessional testingReagentSingle use

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412610129
Basic UDI-DI: 697241261ICH-50295
Reference: ICH-502
EMDN: W0105090101
EMDN description: CHLAMYDIA AG - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:02

Manufacturer products Authorised representative products Authorised representative actors View details

-

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

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611089
Basic UDI-DI: 697241261ICO-502BJ
Reference: ICO-502-01
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD self-testing devicesNot specifiedOn the market

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611256
Basic UDI-DI: B-06972412611256
Reference: 303051
EMDN: -
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BNot specifiedOn the market

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611478
Basic UDI-DI: 0697241261IRS-572BQ
Reference: 303041901
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BNot specifiedOn the market

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611515
Basic UDI-DI: 0697241261IRS-542BF
Reference: 303021901
EMDN: -
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BNot specifiedOn the market

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611522
Basic UDI-DI: 0697241261IRS-542BF
Reference: 303021901
EMDN: -
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: -
Authorised representative: Medunion S.L.
Last updated: 16.06.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD self-testing devicesNot specifiedOn the market

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412611874
Basic UDI-DI: B-06972412611874
Reference: 303036-05
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612017
Basic UDI-DI: B-06972412612017
Reference: 303035
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD generalNot specifiedOn the market

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000033566
UDI-DI: 06972412612024
Basic UDI-DI: B-06972412612024
Reference: 303034
EMDN: -
EMDN description: -
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 13:34

Manufacturer products Authorised representative products Authorised representative actors View details