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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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01.08.2026 13:11

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Active filter:EMDN:W0103020801

7 device results listed.

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PT (INR) test kit (32 tests)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST0180DJ
Basic UDI-DI: B-ST0180DJ
Reference: ST0180
EMDN: W0103020801
EMDN description: PROTHROMBIN TIME RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:32

Manufacturer products View details

TEClot PT-B

PT-B (Owren)

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: TECO Medical Instruments, Production + Trading GmbH
Manufacturer SRN: DE-MF-000022642
UDI-DI: D-PTB-A0260-050G2
Basic UDI-DI: B-PTB-A0260-050G2
Reference: A0260-050
EMDN: W0103020801
EMDN description: PROTHROMBIN TIME RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 17:12

Manufacturer products View details

TruHemo

PT/INR Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065026245042
Basic UDI-DI: B-15065026245042
Reference: TH10002
EMDN: W0103020801
EMDN description: PROTHROMBIN TIME RT & POC
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:37

Manufacturer products Authorised representative products Authorised representative actors View details

Simple Simon PT

IVD generalIVDDOn the marketAnimal tissuesInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Zafena AB
Manufacturer SRN: SE-MF-000024138
UDI-DI: 07333051101109
Basic UDI-DI: B-07333051101109
Reference: ZAF-101
EMDN: W0103020801
EMDN description: PROTHROMBIN TIME RT & POC
First on market country: Sweden
Authorised representative: -
Last updated: 07.07.2026 04:06

Manufacturer products View details

qLabs® PT-INR Owren (Dry) Test Strips

QS-2 Pro

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703160795
Basic UDI-DI: B-06974703160795
Reference: QS-2 Pro
EMDN: W0103020801
EMDN description: PROTHROMBIN TIME RT & POC
First on market country: Sweden
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

qLabs® PT-INR Owren (Dry) Test Strips

QS-2

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Micropoint Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000007991
UDI-DI: 06974703160788
Basic UDI-DI: B-06974703160788
Reference: QS-2
EMDN: W0103020801
EMDN description: PROTHROMBIN TIME RT & POC
First on market country: Sweden
Authorised representative: Obelis s.a.
Last updated: 06.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-02B0006YM

Prothrombin Time Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0006YM
Basic UDI-DI: B-02B0006YM
Reference: 1S001
EMDN: W0103020801
EMDN description: PROTHROMBIN TIME RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details