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VP1

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Sakura Seiki Co., Ltd.
Manufacturer SRN: JP-MF-000022209
UDI-DI: 04946433600485
Basic UDI-DI: 49464331700TD
Reference: 1700
EMDN: W0202059010
EMDN description: TISSUE PROCESSORS
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 31.07.2026 07:26

Manufacturer products Authorised representative products Authorised representative actors View details

Tissue-Tek AutoTEC

AutoTEC a120

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Sakura Seiki Co., Ltd.
Manufacturer SRN: JP-MF-000022209
UDI-DI: 04946433600362
Basic UDI-DI: 49464337090UF
Reference: 7090
EMDN: W0202059004
EMDN description: TISSUE EMBEDDING PROCESSORS
First on market country: Netherlands
Authorised representative: Sakura Finetek Europe B.V.
Last updated: 31.07.2026 07:26

Manufacturer products Authorised representative products Authorised representative actors View details

KABEVETTE G Kit YZ-008B2

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - HARDWARE ACCESSORIES

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921131794
Basic UDI-DI: 4931921IVD0022NT
Reference: YZ-008B2
EMDN: W0202010280
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:23

Manufacturer products Authorised representative products Authorised representative actors View details

Capillary adapter set(20μL) (for measuring CBC+CRP) YZ-008B6

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921005118
Basic UDI-DI: 4931921IVD0021NR
Reference: YZ-008B6
EMDN: W0202010280
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - HARDWARE ACCESSORIES
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

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000047634
UDI-DI: 04897146460036
Basic UDI-DI: 489714646MR002JC
Reference: HT-300
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Hungary
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 31.07.2026 07:18

Manufacturer products Authorised representative products Authorised representative actors View details

FIALine 100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MDX Netherlands Diagnostics inc
Manufacturer SRN: PH-MF-000050095
UDI-DI: 04806541360308
Basic UDI-DI: 480654136POCTANAQJ
Reference: FIALine 100
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

MDX Hemaline 500S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MDX Netherlands Diagnostics inc
Manufacturer SRN: PH-MF-000050095
UDI-DI: 04806541360001
Basic UDI-DI: 480654136HEMAANAFH
Reference: MDX Hemaline 500S
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

04719874742164

X12 PRO

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bonraybio Co., LTD.
Manufacturer SRN: TW-MF-000029512
UDI-DI: 04719874742164
Basic UDI-DI: 471987474X12QT
Reference: X12 PRO
EMDN: W0202059099
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

04719874740559

X1 PRO

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bonraybio Co., LTD.
Manufacturer SRN: TW-MF-000029512
UDI-DI: 04719874740559
Basic UDI-DI: 471987474X10QP
Reference: X1 PRO
EMDN: W0202059099
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

04719874741617

X12 PRO

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bonraybio Co., LTD.
Manufacturer SRN: TW-MF-000029512
UDI-DI: 04719874741617
Basic UDI-DI: 471987474X12QT
Reference: X12 PRO
EMDN: W0202059099
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

04719874740535

X1 PRO

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bonraybio Co., LTD.
Manufacturer SRN: TW-MF-000029512
UDI-DI: 04719874740535
Basic UDI-DI: 471987474X10QP
Reference: X1 PRO
EMDN: W0202059099
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

PL Chip Reservoir set

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: ZACROS Corporation
Manufacturer SRN: JP-MF-000025159
UDI-DI: 04589448510099
Basic UDI-DI: 458944851RS6RS2Z6F
Reference: 18003
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 06:18

Manufacturer products Authorised representative products Authorised representative actors View details

T-TAS wS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ZACROS Corporation
Manufacturer SRN: JP-MF-000025159
UDI-DI: 04589448510075
Basic UDI-DI: 458944851TT1SS2Z6E
Reference: 24001
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 06:18

Manufacturer products Authorised representative products Authorised representative actors View details

T-TAS 01 Total Thrombus Formation Analysis System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: ZACROS Corporation
Manufacturer SRN: JP-MF-000025159
UDI-DI: 04589448510013
Basic UDI-DI: 458944851TT1SR1Z66
Reference: 18001
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 31.07.2026 06:17

Manufacturer products Authorised representative products Authorised representative actors View details

04582643150961

IX85

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Evident Corporation
Manufacturer SRN: JP-MF-000027470
UDI-DI: 04582643150961
Basic UDI-DI: 458264313IX85DP
Reference: N6430700
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Evident Europe GmbH
Last updated: 31.07.2026 06:16

Manufacturer products Authorised representative products Authorised representative actors View details

04582643136064

VS-M1-IVD

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Evident Corporation
Manufacturer SRN: JP-MF-000027470
UDI-DI: 04582643136064
Basic UDI-DI: 458264313VS-M1-IVD4J
Reference: N6404300
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Evident Europe GmbH
Last updated: 31.07.2026 06:16

Manufacturer products Authorised representative products Authorised representative actors View details

04582643135876

IX83

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Evident Corporation
Manufacturer SRN: JP-MF-000027470
UDI-DI: 04582643135876
Basic UDI-DI: 458264313IX83DK
Reference: N6398900
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Evident Europe GmbH
Last updated: 31.07.2026 06:16

Manufacturer products Authorised representative products Authorised representative actors View details

04582643135531

BX53

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Evident Corporation
Manufacturer SRN: JP-MF-000027470
UDI-DI: 04582643135531
Basic UDI-DI: 458264313BX53BR
Reference: N5740400
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Evident Europe GmbH
Last updated: 31.07.2026 06:16

Manufacturer products Authorised representative products Authorised representative actors View details

04582643135340

CKX53

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Evident Corporation
Manufacturer SRN: JP-MF-000027470
UDI-DI: 04582643135340
Basic UDI-DI: 458264313CKX53A4
Reference: N5731900
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Evident Europe GmbH
Last updated: 31.07.2026 06:16

Manufacturer products Authorised representative products Authorised representative actors View details

04582643135326

CX43

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Evident Corporation
Manufacturer SRN: JP-MF-000027470
UDI-DI: 04582643135326
Basic UDI-DI: 458264313CX43BV
Reference: N5731700
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Evident Europe GmbH
Last updated: 31.07.2026 06:16

Manufacturer products Authorised representative products Authorised representative actors View details