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EUDAMED Device Search

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

Last updated

01.08.2026 05:11

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100 device results listed.

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TREPONEMADAT

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIESSE Diagnostica Senese S.p.A
Manufacturer SRN: IT-MF-000013311
UDI-DI: 08033891323936
Basic UDI-DI: 803389132TREPONEMADAT0048
Reference: 26030
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:43

Manufacturer products 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: 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

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: 06972412617494
Basic UDI-DI: 697241261ISY-402MB
Reference: ISY-402-01
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

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: 06972412615933
Basic UDI-DI: 697241261ISY-401M9
Reference: ISY-401-05
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-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: 06972412615230
Basic UDI-DI: 697241261ISY-401M9
Reference: ISY-401-40
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: 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

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

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

Accu-Tell® Syphilis Cassette (Serum/Plasma)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432115
Basic UDI-DI: B-06970581432115
Reference: ABT-STD-B17
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:48

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Syphilis Strip (Serum/Plasma)

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432108
Basic UDI-DI: B-06970581432108
Reference: ABT-STD-A17
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:48

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Syphilis Cassette (Whole Blood/Serum/Plasma)

Cassette

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432092
Basic UDI-DI: B-06970581432092
Reference: ABT-STD-B60
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:48

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Syphilis Strip (Whole Blood/Serum/Plasma)

Strip

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581432085
Basic UDI-DI: B-06970581432085
Reference: ABT-STD-A60
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:48

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test Cassette

Syphilis Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277511179
Basic UDI-DI: B-06970277511179
Reference: ISY-402
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

ISY-U402

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999407435
Basic UDI-DI: B-06952999407435
Reference: ISY-U402
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 28.06.2026 13:51

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Test

SYP-P11, SYP-P23, SYP-W11, SYP-W23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804817657
Basic UDI-DI: B-06952804817657
Reference: SYP-P11 SYP-P23 SYP-W11 SYP-W23
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:31

Manufacturer products Authorised representative products Authorised representative actors View details

SYP-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803834
Basic UDI-DI: B-06952804803834
Reference: SYP-W23F3
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCSYP-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996002363
Basic UDI-DI: B-06950996002363
Reference: GCSYP-402a
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:31

Manufacturer products Authorised representative products Authorised representative actors View details