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Multiplex Fluorescent Analyzer

OG-G260

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00810173653022
Basic UDI-DI: 81017365OG-G2604E
Reference: OG-G260
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 31.07.2026 22:19

Manufacturer products Authorised representative products Authorised representative actors View details

cobas x 480 insrument

185007

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Hamilton AG
Manufacturer SRN: CH-MF-000013585
UDI-DI: 07630032652200
Basic UDI-DI: 76300326185007LC
Reference: 185007
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Austria
Authorised representative: Johner Medical GmbH
Last updated: 31.07.2026 22:02

Manufacturer products Authorised representative products Authorised representative actors View details

Microlab STAR IVD-R

806669

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Hamilton AG
Manufacturer SRN: CH-MF-000013585
UDI-DI: 07630032600119
Basic UDI-DI: 76300326806669NA
Reference: 806669
EMDN: W02060199
EMDN description: ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER
First on market country: Austria
Authorised representative: Johner Medical GmbH
Last updated: 31.07.2026 22:02

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Decoding Reader for Whole Rack

IVD Class ANot specifiedOn the marketDirect marking

Manufacturer: Hangzhou Biobank Bio-technology Co., Ltd.
Manufacturer SRN: CN-MF-000034142
UDI-DI: 16975638844009
Basic UDI-DI: 697563884BB-RWMY
Reference: BQ-A6
EMDN: W02060280
EMDN description: POST-ANALYSIS SAMPLE ARCHIVING SYSTEMS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

Cryogenic Tube

IVD Class ANot specifiedOn the marketSingle use

Manufacturer: Hangzhou Biobank Bio-technology Co., Ltd.
Manufacturer SRN: CN-MF-000034142
UDI-DI: 16975638843002
Basic UDI-DI: 697563884BB-CTLD
Reference: BB-CVO2450-SS2D
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 21:56

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Multi-channel hand-held Screw Cap Recapper

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Biobank Bio-technology Co., Ltd.
Manufacturer SRN: CN-MF-000034142
UDI-DI: 16975638842005
Basic UDI-DI: 697563884BB-MHLK
Reference: BQ-OP8
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Whole Rack Cryogenic Tubes Capper/Decapper

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Biobank Bio-technology Co., Ltd.
Manufacturer SRN: CN-MF-000034142
UDI-DI: 16975638841008
Basic UDI-DI: 697563884BB-ARL3
Reference: BM96
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 31.07.2026 21:56

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HemoScreen

HemoScreen 200

IVD Class BIVDR 2017/746On the marketInstrumentNear-patient testing

Manufacturer: Pixcell Medical Ltd.
Manufacturer SRN: IL-MF-000026612
UDI-DI: 07290016991000
Basic UDI-DI: 7290016991HemoScreen200UW
Reference: HS-FA-30219
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Denmark
Authorised representative: AR Experts B.V.
Last updated: 31.07.2026 21:55

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Automatic Specific Protein Analyzer

CP700, CP710, CP720

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778383
Basic UDI-DI: 697806677CP004KR
Reference: /
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Specific Protein Analyzer

CP880, CP870, CP860

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778352
Basic UDI-DI: 697806677CP003KP
Reference: /
EMDN: W02010299
EMDN description: IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Preparation System

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Longlight Technology Co., Ltd
Manufacturer SRN: CN-MF-000039057
UDI-DI: 06976990130000
Basic UDI-DI: 697699013BoFU001AS
Reference: 202001B0FU100
EMDN: W0202059011
EMDN description: SAMPLE PREPARATION UNITS FOR CHROMOSOMIC ANALYSIS
First on market country: Austria
Authorised representative: GRZAN GROUP SL
Last updated: 31.07.2026 21:51

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Malaria Parasite Scanning and Analysis System

MalaScope-12

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BotuAImaging Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035048
UDI-DI: 06976367040017
Basic UDI-DI: 697636704SH005KZ
Reference: 014
EMDN: W0202030102
EMDN description: AUTOMATED BLOOD GROUPING ANALYSERS
First on market country: Romania
Authorised representative: Kingsmead Service B.V.
Last updated: 31.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

Automated Slide Preparation and Staining System

BP-K

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BotuAImaging Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035048
UDI-DI: 06976263872040
Basic UDI-DI: 697626387SH004N5
Reference: 004
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Romania
Authorised representative: Kingsmead Service B.V.
Last updated: 31.07.2026 21:50

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Automated Blood Cell Morphology Analysis System

Cygnus-K

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BotuAImaging Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035048
UDI-DI: 06976263872033
Basic UDI-DI: 697626387SH003N3
Reference: 003
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Romania
Authorised representative: Kingsmead Service B.V.
Last updated: 31.07.2026 21:50

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360091

BFEX-16、BFEX-32、BFEX-96、BFEX-96E、BFEX-24E、BFEX-32E、BFEX-4E、BFEX-32P、BFEX-16E

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360091
Basic UDI-DI: 697551436BFEX001MK
Reference: BFEX-16
EMDN: W02050106
EMDN description: DNA GENOMIC PREPARATION DEVICES
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details

06975514360015

BFQP-48、BFQP-96、BFQP-16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hangzhou Bigfish Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000027212
UDI-DI: 06975514360015
Basic UDI-DI: 697551436BFQP001PX
Reference: BFQP-4820
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:44

Manufacturer products Authorised representative products Authorised representative actors View details

Automatic Nucleic Acid Purification Instrument

E-96

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000018164
UDI-DI: 06974677691158
Basic UDI-DI: 6974677691158JN
Reference: E-96
EMDN: W0299
EMDN description: IVD INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: PureCE B.V.
Last updated: 31.07.2026 21:43

Manufacturer products Authorised representative products Authorised representative actors View details

06974675464860

BD3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: 06974675464860
Basic UDI-DI: 697467546609029T
Reference: /
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 31.07.2026 21:43

Manufacturer products Authorised representative products Authorised representative actors View details

06974675462965

RT-U600

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: 06974675462965
Basic UDI-DI: 697467546603018T
Reference: /
EMDN: W02010701
EMDN description: URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 31.07.2026 21:43

Manufacturer products Authorised representative products Authorised representative actors View details

06974675462958

RT-S100

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: 06974675462958
Basic UDI-DI: 697467546602018N
Reference: /
EMDN: W0202059099
EMDN description: VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 31.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details