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01.08.2026 16:25

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530 device results listed.

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06938247225204

UG2500

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247225204
Basic UDI-DI: 69382472UG25E-60QX
Reference: UG25E
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06938247222265

Clean I

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247222265
Basic UDI-DI: 69382472CleanI-21WC
Reference: 2060E
EMDN: W0202020185
EMDN description: COAGULOMETERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06938247215014

UP1500

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247215014
Basic UDI-DI: 69382472U15E-16F9
Reference: U15E
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06938247212105

UG1210

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247212105
Basic UDI-DI: 69382472UG121E-10264
Reference: UG121E
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06938247212006

UG1200

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247212006
Basic UDI-DI: 69382472UG12E-101V6
Reference: UG12E
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06938247211290

Cuvettes

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247211290
Basic UDI-DI: 69382472Cuvettes-20S6
Reference: B010E
EMDN: W0202020185
EMDN description: COAGULOMETERS - CONSUMABLES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06938247202410

UG2410

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247202410
Basic UDI-DI: 69382472UG241E-65V7
Reference: UG241E
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06938247202403

UG2400

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247202403
Basic UDI-DI: 69382472UG24E-64QU
Reference: UG24E
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06938247200805

UR8000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247200805
Basic UDI-DI: 69382472U80E-45GL
Reference: UR80E
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06938247200607

UR6000

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247200607
Basic UDI-DI: 69382472U60E-43FN
Reference: UR60E
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

06938247200515

UG500

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Shanghai Sun Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000027682
UDI-DI: 06938247200515
Basic UDI-DI: 69382472UG5E-49Q9
Reference: UG5E
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 19:09

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

Coag M automated coagulometer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992795000301
Basic UDI-DI: 599279506WT
Reference: g-CoagM
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:29

Manufacturer products View details

Coag L automated coagulometer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992795000240
Basic UDI-DI: 599279508WX
Reference: g-CoagL
EMDN: W0202020102
EMDN description: AUTOMATED COAGULOMETERS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:29

Manufacturer products View details

Coag 2D coagulometer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagon Diagnosztikai Korlátolt Felelősségű Társaság
Manufacturer SRN: HU-MF-000023582
UDI-DI: 05992795000226
Basic UDI-DI: 599279502WK
Reference: g-Coag2D
EMDN: W0202020101
EMDN description: SEMI-AUTOMATED COAGULOMETERS
First on market country: Hungary
Authorised representative: -
Last updated: 31.07.2026 16:29

Manufacturer products View details