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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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22.09.2026 04:45

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C1qScreen Class I Positive Control

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IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117017853
Basic UDI-DI: 081211701C1Q5J
Reference: C1QS-PC1
EMDN: W01030402
EMDN description: HLA ANTIBODY SCREENING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 05.08.2026 00:09

Manufacturer products Authorised representative products Authorised representative actors View details

C1qScreen Class II Postive Control

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IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
UDI-DI: 00812117017860
Basic UDI-DI: 081211701C1Q5J
Reference: C1QS-PC2
EMDN: W01030402
EMDN description: HLA ANTIBODY SCREENING
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 05.08.2026 00:09

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Diluent for Hematology Analyzer

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IVD Class AIVDR 2017/746On the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagent

Manufacturer: Zhongshan Chuangyi Biochemical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000033816
UDI-DI: 06978734955917
Basic UDI-DI: 697873495IVDR-A3X
Reference: Many
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:54

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CITRATO SODICO 3.2%

ANTICOAGULANTS - ANCILLARY PRODUCTS

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 08430155003960
Basic UDI-DI: 8430155ANTICOAGYS
Reference: 995959
EMDN: W0103020902
EMDN description: CITRATE
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 22:38

Manufacturer products View details

FORMALDEIDE 4% per Tissue Filling pH 7,2-7,4

FORMALDEIDE AL 4%

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Kaltek S.r.l.
Manufacturer SRN: IT-MF-000019573
UDI-DI: 08055510567583
Basic UDI-DI: 805551056formaldeide_4%BN
Reference: 1659
EMDN: W01030705
EMDN description: FIXING REAGENTS (HISTOLOGY/CYTOLOGY)
First on market country: Italy
Authorised representative: -
Last updated: 04.08.2026 22:36

Manufacturer products View details

Trichrome-Masson stain kit

Trichrome-Masson stain kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804568901
Basic UDI-DI: 697180456HS2211DL
Reference: HS2211
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:16

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Elastic fiber stain kit

Elastic fiber stain kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804568895
Basic UDI-DI: 697180456HS2210DJ
Reference: HS2210
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:16

Manufacturer products Authorised representative products Authorised representative actors View details

Congo red stain kit

Congo red stain kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804568888
Basic UDI-DI: 697180456HS2209DZ
Reference: HS2209
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Periodic acid Schiff-PAS stain kit

Periodic acid Schiff-PAS stain kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804568871
Basic UDI-DI: 697180456HS2208DX
Reference: HS2208
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Acid-fast stain kit

Acid-fast stain kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804568864
Basic UDI-DI: 697180456HS2204DP
Reference: HS2204
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Alcian Blue stain kit

Alcian Blue stain kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804568857
Basic UDI-DI: 697180456HS2203DM
Reference: HS2203
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Iron stain kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804568840
Basic UDI-DI: 697180456HS2202DK
Reference: HS2202
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

AB-PAS stain kit

AB-PAS stain kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804568833
Basic UDI-DI: 697180456HS2201DH
Reference: HS2201
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter pylori stain kit

Helicobacter pylori stain kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804568727
Basic UDI-DI: 697180456HS2206DT
Reference: HS2206
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Mucicarmine stain kit

Mucicarmine stain kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804568710
Basic UDI-DI: 697180456HS2207DV
Reference: HS2207
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Methenamine sliver stain kit

Methenamine sliver stain kit

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804566563
Basic UDI-DI: 697180456HS2213DQ
Reference: HS2213
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Primary Antibody Diluent

Primary Antibody Diluent

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Henan Celnovte Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000022882
UDI-DI: 06971804565597
Basic UDI-DI: 697180456SD2005CR
Reference: SD2005
EMDN: W01030708
EMDN description: STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)
First on market country: Türkiye
Authorised representative: Umedwings Netherlands B.V.
Last updated: 04.08.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

Immersion Oil

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Baso Diagnostics Inc. Zhuhai
Manufacturer SRN: CN-MF-000050424
UDI-DI: 06952383306184
Basic UDI-DI: 695238330005GK
Reference: 20ml
EMDN: W01030799
EMDN description: HISTOLOGY / CYTOLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 04.08.2026 22:14

Manufacturer products Authorised representative products Authorised representative actors View details

BC-3D Hematology Control

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053022484
Basic UDI-DI: 69449040AB70000063U
Reference: 105-028606-00
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:12

Manufacturer products Authorised representative products Authorised representative actors View details

BR60 Hematology Control，SC-CAL RET Hematology Calibrator

IVD Class BIVDR 2017/746On the marketReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053011310
Basic UDI-DI: 69449040XQSJ-003F******7Y
Reference: 3mL× 1
EMDN: W0103010507
EMDN description: WHOLE BLOOD CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:12

Manufacturer products Authorised representative products Authorised representative actors View details