Public EUDAMED Search

EUDAMED Device Search

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

TR EN

Last updated

20.09.2026 20:12

Sync status

Successful

Device

3108040

Actor

47631

Certificate

3283

Filters

Show filters

Active filter:EMDN:W0102100101

149 device results listed.

Page 3 / 8

CSV XML

BlueDiverDot ANA + DFS-70 IgG

BlueDiver Dot

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagent

Manufacturer: D-tek s.a.
Manufacturer SRN: BE-MF-000024530
UDI-DI: 05425023681695
Basic UDI-DI: 542502368BDDANAYE
Reference: RLH12DIV-24
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Belgium
Authorised representative: -
Last updated: 16.07.2026 09:59

Manufacturer products View details

iStar-ANA

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76359GB
Basic UDI-DI: B-DC76359GB
Reference: DC76359
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-ANA

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76358G9
Basic UDI-DI: B-DC76358G9
Reference: DC76358
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-ANA

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76360FU
Basic UDI-DI: B-DC76360FU
Reference: DC76360
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-ANA

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76357G7
Basic UDI-DI: B-DC76357G7
Reference: DC76357
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:12

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-ANA

30 Tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76061FF
Basic UDI-DI: B-DC76061FF
Reference: DC76061
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 16:03

Manufacturer products Authorised representative products Authorised representative actors View details

ANA screen

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147196424
Basic UDI-DI: B-86060147196424
Reference: N707A24ANA
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:14

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-ANA

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723455
Basic UDI-DI: 692591270039HC
Reference: C89033G-S
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

ANA IgG CLIA Microparticles

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359514538
Basic UDI-DI: 697015090000326HH
Reference: CMQ3310
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

ANA IgG CLIA Microparticles

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544160
Basic UDI-DI: 697015090000326HH
Reference: CMQ3303
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

ANA IgG CLIA Microparticles

IVD Class BNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544184
Basic UDI-DI: 697015090000326HH
Reference: CMQ3305
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

08435287148749

AUTOANTIBODIES DUO-HEp2/ML (DUO-HEp2/ML)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148749
Basic UDI-DI: B-08435287148749
Reference: 44874
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:51

Manufacturer products View details

08435287147858

ANA-SCREENING

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287147858
Basic UDI-DI: B-08435287147858
Reference: 44785
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:50

Manufacturer products View details

08435287145465

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287145465
Basic UDI-DI: B-08435287145465
Reference: 44546
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287144475

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144475
Basic UDI-DI: B-08435287144475
Reference: 44547
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287144093

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144093
Basic UDI-DI: B-08435287144093
Reference: 44509
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287144086

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287144086
Basic UDI-DI: B-08435287144086
Reference: 44508
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

08435287141085

ANTI-NUCLEAR ANTIBODIES HEp-2 (ANA-HEp-2)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287141085
Basic UDI-DI: B-08435287141085
Reference: 44108
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:48

Manufacturer products View details

QUANTA Flash

QUANTA Flash® CTD Screen Plus Reagents

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle useSterile

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950627791
Basic UDI-DI: B-08426950627791
Reference: 701220
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:22

Manufacturer products Authorised representative products Authorised representative actors View details

NOVA Lite

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950621843
Basic UDI-DI: B-08426950621843
Reference: 704320
EMDN: W0102100101
EMDN description: ANA SCREENING
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:21

Manufacturer products Authorised representative products Authorised representative actors View details