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

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iFlash-FDP

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912736295
Basic UDI-DI: 692591270288J3
Reference: C86138-S
EMDN: W0103020502
EMDN description: FIBRINOGEN DEGRADATION PRODUCTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:37

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-t-PAIC

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912736288
Basic UDI-DI: 692591270290HN
Reference: C86122
EMDN: W0103020599
EMDN description: FIBRINOLYSIS TESTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-PIC

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912736271
Basic UDI-DI: 692591270291HQ
Reference: C86123
EMDN: W0103020305
EMDN description: PLASMIN - A2 - ANTIPLASMIN COMPLEX
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-TAT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912736264
Basic UDI-DI: 692591270292HS
Reference: C86151
EMDN: W0103020307
EMDN description: THROMBIN-ANTITHROMBIN III-COMPLEX
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-TM

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912736257
Basic UDI-DI: 692591270289J5
Reference: C86140
EMDN: W0103020699
EMDN description: COAGULATION INHIBITORS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-D-dimer

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912711360
Basic UDI-DI: 692591270152H9
Reference: C86238
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Diluent

Blood Coagulation

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577542
Basic UDI-DI: 69257945W0103020903R0PT
Reference: 3019961
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Blood Coagulation Analyzer Detergent II

Automatic Blood Coagulation Analyzer Detergent

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794577511
Basic UDI-DI: 69257945W0103020999R0SQ
Reference: 3019962
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:28

Manufacturer products Authorised representative products Authorised representative actors View details

Dia-CaCl2

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992791410487
Basic UDI-DI: 599279141W9
Reference: 41048
EMDN: W0103020901
EMDN description: CALCIUM CHLORIDE
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:29

Manufacturer products View details

Dia-IMIDAZOL

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992791211800
Basic UDI-DI: 599279121W3
Reference: 21180
EMDN: W0103020903
EMDN description: BUFFERS (HAEMOSTASIS)
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:28

Manufacturer products View details

Dia-WASH

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992791131801
Basic UDI-DI: 599279113W4
Reference: 13180
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:28

Manufacturer products View details

Dia-SORB

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992791111803
Basic UDI-DI: 599279111VY
Reference: 11180
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:28

Manufacturer products View details

Cytrynian trisodowy 3,2% 100ml

Antykoagulanty do pobierania krwi

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: KOLASA SPÓŁKA JAWNA
Manufacturer SRN: PL-MF-000044993
UDI-DI: 05906492941041
Basic UDI-DI: 590649294ADPKJN
Reference: 2001.5
EMDN: W0103020902
EMDN description: CITRATE
First on market country: Poland
Authorised representative: -
Last updated: 31.07.2026 14:16

Manufacturer products View details

Thromboplastin L

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013016557
Basic UDI-DI: 505601300PTMR
Reference: 5265L
EMDN: W0103020101
EMDN description: PROTHROMBIN TIME ( QUICK TEST )
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

CA CAL S

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562509522
Basic UDI-DI: 4987562CACALSYU
Reference: 01412728
EMDN: W01030299
EMDN description: HAEMOSTASIS REAGENTS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:36

Manufacturer products Authorised representative products Authorised representative actors View details

04987562499717

CN-COAGWASHER

IVD Class AIVDR 2017/746On the marketProfessional testing

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562499717
Basic UDI-DI: 4987562CN-COAGWASHER7C
Reference: AZ700649
EMDN: W01030299
EMDN description: HAEMOSTASIS REAGENTS - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:36

Manufacturer products Authorised representative products Authorised representative actors View details

CA CLEAN II

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: SYSMEX CORPORATION
Manufacturer SRN: JP-MF-000014037
UDI-DI: 04987562200436
Basic UDI-DI: 4987562CACLEANIIG6
Reference: 974-0581-0
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: Germany
Authorised representative: Sysmex Europe SE
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

04987506017038

HEXAMATE Factor XIII-Control I/II

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testing

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506017038
Basic UDI-DI: 498750601703JV
Reference: 04942371R
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

04987506017021

HEXAMATE Factor XIII - Calibrator

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testing

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506017021
Basic UDI-DI: 498750601702JT
Reference: 04942362R
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details

04987506017014

HEXAMATE Factor XIII

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Manufacturer SRN: JP-MF-000017864
UDI-DI: 04987506017014
Basic UDI-DI: 498750601701JR
Reference: 04942354R
EMDN: W0103020213
EMDN description: COAGULATION FACTOR XIII
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 07:34

Manufacturer products Authorised representative products Authorised representative actors View details