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Blood Coagulation Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301103
Basic UDI-DI: 6936895BS01125
Reference: BS011
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

Auto ESR Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895301097
Basic UDI-DI: 6936895BS01227
Reference: BS012
EMDN: W02029001
EMDN description: ERYTHROCYTE SEDIMENTATION RATE DEVICES
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

Manufacturer products Authorised representative products Authorised representative actors View details

06936895300380

Auto Hematology Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300380
Basic UDI-DI: 6936895BS01023
Reference: BS010
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

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5-Part Auto Hematology Analyzer

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Biobase Biodustry(Shandong) Co.,Ltd.
Manufacturer SRN: CN-MF-000025015
UDI-DI: 06936895300342
Basic UDI-DI: 6936895BS0092J
Reference: BS009
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 31.07.2026 19:00

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06935091670273

HT-300

IVD Class BIVDR 2017/746Not intended for EU marketInstrumentProfessional testing

Manufacturer: Qingdao Hightop Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000016890
UDI-DI: 06935091670273
Basic UDI-DI: 69350916HT206M7
Reference: /
EMDN: W02020601
EMDN description: RAPID TEST CELL COUNT INSTRUMENTS
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 18:57

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BGM-202 Blood Glucose Monitoring System

BGM-202

IVD Class AIVDR 2017/746No longer on the marketInstrumentKitProfessional testing

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260213221
Basic UDI-DI: 69332602IT0100009A9
Reference: BT0000701
EMDN: W02020699
EMDN description: RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: Sungo Cert GmbH
Last updated: 31.07.2026 18:56

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06928103082102

Auto FICA-300

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Daan Gene Co., Ltd.
Manufacturer SRN: CN-MF-000025799
UDI-DI: 06928103082102
Basic UDI-DI: 69281030821XFY
Reference: DA8210
EMDN: W02020501
EMDN description: HISTOLOGICAL SAMPLES ANALYSERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:46

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06926802610213

Haema N7/Haema N7p/Haema N9/Haema N9p/Haema NX/Haema NXp

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802610213
Basic UDI-DI: 69268026HaemaN900000001X2
Reference: Haema NX
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:42

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Fully Automated Blood Grouping System

BT-30, BT-31

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604045
Basic UDI-DI: 69268026BT30000000000018J
Reference: BT-30
EMDN: W0202030102
EMDN description: AUTOMATED BLOOD GROUPING ANALYSERS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

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06926802604021

BT-70, BT-71

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604021
Basic UDI-DI: 69268026BT70000001N8
Reference: BT-70
EMDN: W0202030102
EMDN description: AUTOMATED BLOOD GROUPING ANALYSERS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:41

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Haemostasis Analyzer

Haema T4, Haema T4S

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802602829
Basic UDI-DI: 69268026HameaT4001MJ
Reference: Haema T4
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:40

Manufacturer products Authorised representative products Authorised representative actors View details

Fully-automated Haemostasis Analyzer

Haema TX, Haema TA

IVD Class AIVDR 2017/746On the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802602690
Basic UDI-DI: 69268026HameaTX001V7
Reference: Haema TX
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 31.07.2026 18:40

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BSP-800 Automated Hematology Smear Slide Processor

BSP-800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794575685
Basic UDI-DI: 69257945W0202059002D0QR
Reference: 3019712
EMDN: W0202059002
EMDN description: AUTOMATED SLIDE STAINERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

BCA-1000 Automatic Blood Coagulation Analyzer

BCA-1000 BCA-3000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794515001
Basic UDI-DI: 69257945W0202020102D0KU
Reference: 3009736
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 31.07.2026 18:27

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06921807615218

CFMS LEPU-8880

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807615218
Basic UDI-DI: 692180760034EQ
Reference: CFMS LEPU-8880
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Italy
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

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Glycated Hemoglobin Analyzer HAM111

HAM111

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentKitProfessional testing

Manufacturer: BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000033011
UDI-DI: 06921807611456
Basic UDI-DI: 692180764007FH
Reference: JY45HAM111
EMDN: W02029099
EMDN description: VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
First on market country: France
Authorised representative: Lepu Medical (Europe) Cooperatief U.A.
Last updated: 31.07.2026 18:11

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Primostar 3

Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 1

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Carl Zeiss Suzhou Co., Ltd.
Manufacturer SRN: CN-MF-000017606
UDI-DI: 06909262200187
Basic UDI-DI: 6909262CNA003QD
Reference: 415501-0001-000
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Carl Zeiss Microscopy GmbH
Last updated: 31.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Stemi 305

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Carl Zeiss Suzhou Co., Ltd.
Manufacturer SRN: CN-MF-000017606
UDI-DI: 06909262200163
Basic UDI-DI: 6909262CNA001Q9
Reference: 435063-9010-000
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Carl Zeiss Microscopy GmbH
Last updated: 31.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

Axio Vert. A1

Axiovert 5 / Primovert / Axio Vert.A1/Axiovert 7

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Carl Zeiss Suzhou Co., Ltd.
Manufacturer SRN: CN-MF-000017606
UDI-DI: 06909262200040
Basic UDI-DI: 6909262CNA002QB
Reference: 431030-9000-000
EMDN: W0202050303
EMDN description: OPTICAL LABORATORY MICROSCOPES
First on market country: Germany
Authorised representative: Carl Zeiss Microscopy GmbH
Last updated: 31.07.2026 18:05

Manufacturer products Authorised representative products Authorised representative actors View details

06429810590077

Ocus M 20 MGU-30009

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Grundium Oy
Manufacturer SRN: FI-MF-000005144
UDI-DI: 06429810590077
Basic UDI-DI: 6429810590MGU30009PB
Reference: MGU-30009
EMDN: W0202050304
EMDN description: DIGITAL LABORATORY MICROSCOPES
First on market country: Finland
Authorised representative: -
Last updated: 31.07.2026 17:40

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