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EUDAMED Device Search

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

Last updated

17.09.2026 19:17

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Active filter:EMDN:W0102160201

6 device results listed.

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R01-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571801211
Basic UDI-DI: B-06941571801211
Reference: R01-112
EMDN: W0102160201
EMDN description: BTA - RT & POC
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 03.08.2026 14:47

Manufacturer products Authorised representative products Authorised representative actors View details

R01-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571801204
Basic UDI-DI: B-06941571801204
Reference: R01-112-01
EMDN: W0102160201
EMDN description: BTA - RT & POC
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 03.08.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

R01-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571801105
Basic UDI-DI: B-06941571801105
Reference: R01-110
EMDN: W0102160201
EMDN description: BTA - RT & POC
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 03.08.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

R01S-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571801006
Basic UDI-DI: B-06941571801006
Reference: R01S-112
EMDN: W0102160201
EMDN description: BTA - RT & POC
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 03.08.2026 14:46

Manufacturer products Authorised representative products Authorised representative actors View details

Bladder Tumor Antigen Rapid Test Cassette (Urine)

GEBTA-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEBTA-102aHGSW
Basic UDI-DI: B-GEBTA-102aHGSW
Reference: GEBTA-102a
EMDN: W0102160201
EMDN description: BTA - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Lepzi BTA Test

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Lepzi Diagnostika Ltd.
Manufacturer SRN: BG-MF-000051504
UDI-DI: 03800502152088
Basic UDI-DI: B-03800502152088
Reference: LD_BG006
EMDN: W0102160201
EMDN description: BTA - RT & POC
First on market country: Bulgaria
Authorised representative: -
Last updated: 05.07.2026 22:36

Manufacturer products View details