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70 device results listed.

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06975838803434

0.5mL×1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838803434
Basic UDI-DI: B-06975838803434
Reference: HE50149
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

06975838802789

0.625mL×1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838802789
Basic UDI-DI: B-06975838802789
Reference: HE50150
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

06975838801645

0.625mL×1

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838801645
Basic UDI-DI: B-06975838801645
Reference: HE50147
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

Coagulation 2 Test Panel

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838800617
Basic UDI-DI: B-06975838800617
Reference: HE50072
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: MedPath GmbH
Last updated: 07.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

Coagulation 4 Test Panel

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838800600
Basic UDI-DI: B-06975838800600
Reference: HE50009
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

Coagulation 5 Test Panel

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Pushkang Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000042656
UDI-DI: 06975838800594
Basic UDI-DI: B-06975838800594
Reference: HE50008
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: Sungo Cert GmbH
Last updated: 07.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

Perosphere ClotChek

1100005

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testing

Manufacturer: Perosphere Technologies Inc.
Manufacturer SRN: US-MF-000048660
UDI-DI: 00850032840200
Basic UDI-DI: B-00850032840200
Reference: 1100005
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Germany
Authorised representative: Qualrep Services B.V.
Last updated: 05.07.2026 11:01

Manufacturer products Authorised representative products Authorised representative actors View details

ClotChek Cuvettes (20 Pack), Global

1100002

IVD generalIVDDOn the marketNear-patient testingProfessional testingSingle use

Manufacturer: Perosphere Technologies Inc.
Manufacturer SRN: US-MF-000048660
UDI-DI: 00850032840040
Basic UDI-DI: B-00850032840040
Reference: 1100002
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Germany
Authorised representative: Qualrep Services B.V.
Last updated: 05.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

00845275000573

100597, J100597

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Fisher Diagnostics A division of Fisher Scientific Company, LLC
Manufacturer SRN: US-MF-000029041
UDI-DI: 00845275000573
Basic UDI-DI: B-00845275000573
Reference: 100597, J100597
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: B·R·A·H·M·S GmbH
Last updated: 05.07.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

MRX PT Owren

PT Owren

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320073
Basic UDI-DI: 7350060320036Q
Reference: K5026
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:02

Manufacturer products View details

Coagulation Analyzer

BCA Series, CA Series

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Infitek Co., Ltd.
Manufacturer SRN: CN-MF-000048840
UDI-DI: 06978507780241
Basic UDI-DI: 697850778BCA10L5
Reference: IN0126
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
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

06926802615485

Heparin Assay

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802615485
Basic UDI-DI: 69268026MD78C000000000134
Reference: MCT01401E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802615454

Extrinsic Activated Thromboelastography

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802615454
Basic UDI-DI: 69268026MD78B000000000125
Reference: MCT01201E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802615423

Aprotinin Inhibited Thromboelastography

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802615423
Basic UDI-DI: 69268026MD78A0000000001Z3
Reference: MCT01101E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603918

IVD Class CNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603918
Basic UDI-DI: 69268026MD66B00001W7
Reference: MCT00202E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603925

IVD Class CNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603925
Basic UDI-DI: 69268026MD66B00001W7
Reference: MCT00203E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603932

IVD Class CNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603932
Basic UDI-DI: 69268026MD66B00001W7
Reference: MCT00204E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 05:34

Manufacturer products Authorised representative products Authorised representative actors View details

Tsmart FIB Batrox

IVD Class CIVDR 2017/746No longer on the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678606170
Basic UDI-DI: 353267F00192P8T
Reference: 860617
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:26

Manufacturer products View details

Coagulation Analyzer Sample Diluent（CASD）

10.0 mL×12, 20.0 mL×12

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416821
Basic UDI-DI: 69506174BL21050372
Reference: BL2101503
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Türkiye
Authorised representative: Humiss International B.V.
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

06926802615478

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802615478
Basic UDI-DI: 69268026MD78B000000000125
Reference: MCT01203E
EMDN: W0103020199
EMDN description: GENERAL COAGULATION TESTS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 17.06.2026 06:01

Manufacturer products Authorised representative products Authorised representative actors View details