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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Motic

AE31E AE2000 PX43 BIO

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Motic China Group Co., Ltd.
Manufacturer SRN: CN-MF-000033671
UDI-DI: 06973967160572
Basic UDI-DI: 697396716IBMicroscopeM2
Reference: AE2000
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

Motic

Panthera E2 Panthera C2 Panthera DL Panthera Cloud PA43 PA53 BIO BA210E BA210LED BA310E BA310LED BA410E 50W BA410E 100W

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Motic China Group Co., Ltd.
Manufacturer SRN: CN-MF-000033671
UDI-DI: 06973967160114
Basic UDI-DI: 697396716Microscope001BG
Reference: Panthera DL
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:35

Manufacturer products Authorised representative products Authorised representative actors View details

06972337851591

G20, G21, G60, G80

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: B&E BIO-TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000023256
UDI-DI: 06972337851591
Basic UDI-DI: 697233785GHgbA010ME
Reference: G20
EMDN: W0201060101
EMDN description: GLYCOSILATED HEMOGLOBIN DEVICEs
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 21:31

Manufacturer products Authorised representative products Authorised representative actors View details

Medical Centrifuge LX-75L2400R

Medical Centifuge

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Qingdao Haier Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000039043
UDI-DI: 06949573549971
Basic UDI-DI: 697444022LX002EJ
Reference: BE13K3000
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:31

Manufacturer products Authorised representative products Authorised representative actors View details

Medical Centrifuge LX-165T2R

Medical Centrifuge

IVD Class AIVDR 2017/746On the marketDirect markingInstrument

Manufacturer: Qingdao Haier Biomedical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000039043
UDI-DI: 06949573525104
Basic UDI-DI: 697444022LX001EG
Reference: BE0J0101T
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:31

Manufacturer products Authorised representative products Authorised representative actors View details