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01.08.2026 18:27

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246 device results listed.

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06979497340019

HXC-01、HXC-02、HXC-03、HXC-04、HXC-05、HXC-06

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Jiangsu Hongen Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000051431
UDI-DI: 06979497340019
Basic UDI-DI: 697949734FADESRA0139
Reference: HXC-01
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.07.2026 00:45

Manufacturer products Authorised representative products Authorised representative actors View details

06978969680004

ASPS 9600、ASPS 6000、ASPS 9600 Plus、ASPS 6000 Plus

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Motic (Xiamen) Medical Diagnostic Systems Co.,Ltd
Manufacturer SRN: CN-MF-000052629
UDI-DI: 06978969680004
Basic UDI-DI: 697896968Automated3S
Reference: ASPS 9600
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.07.2026 00:17

Manufacturer products Authorised representative products Authorised representative actors View details

ESR Analyzer

ESRA Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780197
Basic UDI-DI: 697850778ESR10TB
Reference: IN0127
EMDN: W02029001
EMDN description: ERYTHROCYTE SEDIMENTATION RATE DEVICES
First on market country: Türkiye
Authorised representative: Kingsmead Service B.V.
Last updated: 02.07.2026 23:37

Manufacturer products Authorised representative products Authorised representative actors View details

Raman-Activated Microfluidic Sorter (RAMS)

RAMS MM96

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Qingdao Single-Cell Biotech. Co., Ltd.
Manufacturer SRN: CN-MF-000047609
UDI-DI: 06977908840011
Basic UDI-DI: 697790884MM96VD
Reference: IVDR
EMDN: W02029007
EMDN description: IMMUNOMAGNETIC CELLULAR SEPARATION SYSTEMS
First on market country: France
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 23:07

Manufacturer products Authorised representative products Authorised representative actors View details

KUOHAI TECHNOLOGY

KH-TB,KH-TP,KH-TC,KH-TS,KH-TK,KH-TD,KH-TE,KH-TH,KH-TQ,KH-TO;

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Xiaogan Kuohai Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000040038
UDI-DI: 06977185070002
Basic UDI-DI: 697718507KHTPTC
Reference: KH-TB
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 22:15

Manufacturer products Authorised representative products Authorised representative actors View details

SeekOne™ Microfluidic Control System

M004A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Beijing SeekGene BioSciences Co.,Ltd
Manufacturer SRN: CN-MF-000034144
UDI-DI: 06976241370155
Basic UDI-DI: 697624137015KC
Reference: M004A
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 20:54

Manufacturer products Authorised representative products Authorised representative actors View details

SeekOne™ Digital Droplet System

M001A

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Beijing SeekGene BioSciences Co.,Ltd
Manufacturer SRN: CN-MF-000034144
UDI-DI: 06976241370148
Basic UDI-DI: 697624137014KA
Reference: M001A
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 02.07.2026 20:54

Manufacturer products Authorised representative products Authorised representative actors View details

06975866146633

Automatic Liquid-Based Cytology Slide Preparation and Staining Machine

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Wuhan Landing Intelligence Medical Co., Ltd.
Manufacturer SRN: CN-MF-000030678
UDI-DI: 06975866146633
Basic UDI-DI: 697586614MIS007T8
Reference: LD-ZR 24
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:12

Manufacturer products Authorised representative products Authorised representative actors View details

ESR Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000040107
UDI-DI: 06975488440041
Basic UDI-DI: 697548844ESR22SU
Reference: ESRA-10
EMDN: W02029001
EMDN description: ERYTHROCYTE SEDIMENTATION RATE DEVICES
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 19:07

Manufacturer products Authorised representative products Authorised representative actors View details

06972337852222

i-Check i-Check 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337852222
Basic UDI-DI: 697233785i-CheckA012MJ
Reference: i-Check
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 12:43

Manufacturer products Authorised representative products Authorised representative actors View details

Digital Slide Scanning & Imaging System

LTS-BL200, LTS-BL400, LTS-BL600, LTS-BL1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hunan Lituo Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000029972
UDI-DI: 06972129852027
Basic UDI-DI: 697212985BL100094
Reference: LTS-BL200
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 02.07.2026 12:34

Manufacturer products Authorised representative products Authorised representative actors View details

CITOTEST

Marking Pen

Class IMDR 2017/745On the market

Manufacturer: CITOTEST LABWARE MANUFACTURING CO.,LTD
Manufacturer SRN: CN-MF-000017214
UDI-DI: 06975085645177
Basic UDI-DI: 697079159MAPA000A00NE2
Reference: 6000-0001
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Austria
Authorised representative: Wellkang Ltd
Last updated: 02.07.2026 11:31

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Digital Cell Morphology Analyzer

MC-80、MC-82

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415988401
Basic UDI-DI: 69449040AB3000005ZK
Reference: MC-80
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

03770027071020

CLEOCT1.0

IVD Class AIVDR 2017/746On the market

Manufacturer: Primaa
Manufacturer SRN: FR-MF-000016215
UDI-DI: 03770027071020
Basic UDI-DI: 3770027071PRM_CL_CTW2
Reference: CLEOCT1.O
EMDN: W02029082
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 16:08

Manufacturer products View details

myStage Dx

IVD Class CIVDR 2017/746On the marketProfessional testing

Manufacturer: SPOTLIGHT MEDICAL
Manufacturer SRN: FR-MF-000043253
UDI-DI: 37604168900048
Basic UDI-DI: 3760416890SPOTLIGHT00142
Reference: myStage Dx
EMDN: W02029092
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:50

Manufacturer products View details

miniiSED

112-01017

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Alcor Scientific
Manufacturer SRN: US-MF-000029295
UDI-DI: 00896406002874
Basic UDI-DI: 0896406002miniiSEDSD
Reference: 112-01017
EMDN: W02029001
EMDN description: ERYTHROCYTE SEDIMENTATION RATE DEVICES
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 01.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

iSED

112-00101

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Alcor Scientific
Manufacturer SRN: US-MF-000029295
UDI-DI: 00896406002508
Basic UDI-DI: 0896406002iSED2Elite5D
Reference: 112-00101
EMDN: W02029001
EMDN description: ERYTHROCYTE SEDIMENTATION RATE DEVICES
First on market country: Croatia
Authorised representative: Emergo Europe B.V.
Last updated: 01.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

CellaVision® BMA Review Software, version 1.0

CellaVision® Bone Marrow Aspirate Application

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: CellaVision AB
Manufacturer SRN: SE-MF-000002377
UDI-DI: 07350040977477
Basic UDI-DI: 735004097CBMA-RYQ
Reference: CBMA-R10
EMDN: W02029092
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

CellaVision® BMA Analyzer Software, for DC-1, version 1.0

CellaVision® Bone Marrow Aspirate Application

IVD Class CIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: CellaVision AB
Manufacturer SRN: SE-MF-000002377
UDI-DI: 07350040977460
Basic UDI-DI: 735004097CBMA-AXN
Reference: CBMA-A0110
EMDN: W02029092
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Sweden
Authorised representative: -
Last updated: 30.06.2026 12:48

Manufacturer products View details

Liquid-based Thin-layer cytology processor

YGR-Z01、YGR-Z02、YGR-Z03、YGR-LBC-04

IVD Class AIVDR 2017/746On the marketInstrument

Manufacturer: Hangzhou Yiguoren Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000003616
UDI-DI: 06970413352468
Basic UDI-DI: 697041335YGR2003EU8F
Reference: YGR-LBC-04
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: BioDomi GmbH
Last updated: 30.06.2026 03:11

Manufacturer products Authorised representative products Authorised representative actors View details