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

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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

"D-dimer Control DD-QC"

CONTROL PLASMA FOR HAEMOSTASIS

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921050699
Basic UDI-DI: 4931921IVD0025NZ
Reference: DD-QC
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

"D-dimer Calibrator DD-CAL"

CALIBRATION PLASMA FOR HAEMOSTASIS

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921050682
Basic UDI-DI: 4931921IVD0024NX
Reference: DD-CAL
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Celltac chemi D-dimer DD-421W

D-DIMER

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921050675
Basic UDI-DI: 4931921IVD0026P3
Reference: DD-421W
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Yumizen G Clean SYS

1300036421

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008485
Basic UDI-DI: 361023ymz_g_clean_sys96
Reference: 1300036421
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen G CLEANER

1300036420

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008478
Basic UDI-DI: 361023ymz_g_cleanerP2
Reference: 1300036420
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen G SORB

1300036418

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008461
Basic UDI-DI: 361023ymz_g_sorbN7
Reference: 1300036418
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:16

Manufacturer products View details

Yumizen G CAL

1300036416

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008423
Basic UDI-DI: 361023ymz_g_cal94
Reference: 1300036416
EMDN: W0103020701
EMDN description: CALIBRATION PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Yumizen G CTRL I & II

1300036412

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008416
Basic UDI-DI: 361023ymz_g_contKF
Reference: 1300036412
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Yumizen G CaCl2 4

1300036386

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008409
Basic UDI-DI: 361023ymz_g_cacl2RT
Reference: 1300036386
EMDN: W0103020901
EMDN description: CALCIUM CHLORIDE
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

Yumizen G IMIDAZOL

1300036385

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

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230008393
Basic UDI-DI: 361023ymz_g_imidazol3W
Reference: 1300036385
EMDN: W0103020999
EMDN description: AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:15

Manufacturer products View details

sthemO AT L

sthemO AT

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450013030
Basic UDI-DI: 360745099AT0003ZK
Reference: 01303
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details