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

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04.08.2026 18:01

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590 device results listed.

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D-600400MR

Gesunder Darm

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-600400MR
Basic UDI-DI: B-600400MR
Reference: 600400
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 03:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-569793559221729W

Urine Reagent Strips(Dry Chemical Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: D-569793559221729W
Basic UDI-DI: B-569793559221729W
Reference: 1 piece/bag x 100
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 17.07.2026 02:48

Manufacturer products Authorised representative products Authorised representative actors View details

16977376430032

300 Tests, 600 Tests

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagentSingle use

Manufacturer: Xiamen Talent Biomedical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000039397
UDI-DI: 16977376430032
Basic UDI-DI: 697737643DD23MY
Reference: DD23-300
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

Wash Reagent

Please see the IFU

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Hotgen (Langfang) Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000018899
UDI-DI: 06977724273796
Basic UDI-DI: 697541776004014J
Reference: HGOTHER09
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 16.07.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

High-Voltage Adjustment Reagent

50T, 2×50T

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062631
Basic UDI-DI: 69703416803205069JX
Reference: 0320507204
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST Presepsin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301254
Basic UDI-DI: 4987595PF1201KX3
Reference: 30125
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7020 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Antigen Retrieval 2 (AR2), low pH

Oncore Pro Antigen Retrieval Systems

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627031853
Basic UDI-DI: 08476270BOPAGRETYX
Reference: OPRI6005T60
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Dewax Solution Kit

Dewaxing Reagents of IHC

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627031846
Basic UDI-DI: 08476270BDEWAXH2
Reference: OPRI6004KT60
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:02

Manufacturer products Authorised representative products Authorised representative actors View details

Carbohydrate Antigen 125 Test Kit (FIA)

VID100

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID100ED
Basic UDI-DI: B-VID100ED
Reference: VID100-06-011
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:19

Manufacturer products Authorised representative products Authorised representative actors View details

ALT (SGPT)

Reagent 1:2x100mL ,Reagent 2:2x25mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Bioanalytic Diagnostik Kimya Sanayi ve Ticaret Limited Şirketi
Manufacturer SRN: TR-MF-000034087
UDI-DI: D-8681554453218AJ
Basic UDI-DI: B-8681554453218AJ
Reference: B80019
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 12.07.2026 15:42

Manufacturer products View details

D-469793559221728K

Urine Reagent Strips(Dry Chemical Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: D-469793559221728K
Basic UDI-DI: B-469793559221728K
Reference: 1 piece/bag x 60
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 11.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems ASO Anti-Streptolysin Reagent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447620QC
Basic UDI-DI: B-447620QC
Reference: 447620
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-447480QL
Basic UDI-DI: B-447480QL
Reference: 447480
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

D-3697935592217278

Urine Reagent Strips(Dry Chemical Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: D-3697935592217278
Basic UDI-DI: B-3697935592217278
Reference: 1 piece/bag x 50
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 11.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

Access CEA Diluent

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-33206FS
Basic UDI-DI: B-33206FS
Reference: 33206
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

D-269793559221725V

Urine Reagent Strips(Dry Chemical Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: D-269793559221725V
Basic UDI-DI: B-269793559221725V
Reference: 1 piece/bag x 35
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 11.07.2026 16:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-19074

D-Dimer Assay Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-19074
Basic UDI-DI: B-19074
Reference: /
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 14:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-169793559221724J

Urine Reagent Strips(Dry Chemical Method)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000050949
UDI-DI: D-169793559221724J
Basic UDI-DI: B-169793559221724J
Reference: 1 piece/bag x25
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 11.07.2026 10:16

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Streptolysin O [ASO] Kit

Anti-Streptolysin O [ASO] Kit 183mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555616395
Basic UDI-DI: B-08683555616395
Reference: B34030
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:43

Manufacturer products View details

URINARY PROTEIN Kit

URINARY PROTEIN Kit 120mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ
Manufacturer SRN: TR-MF-000040334
UDI-DI: 08683555616296
Basic UDI-DI: B-08683555616296
Reference: B33301
EMDN: W01029099
EMDN description: IMMUNOCHEMISTRY REAGENTS - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 00:43

Manufacturer products View details