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ARC Sterile Radial Compression Device

RCB-0047

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: TZ Medical inc
Manufacturer SRN: US-MF-000027311
UDI-DI: 00811331011494
Basic UDI-DI: 081133101RCB-0047JC
Reference: RCB-0047
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details

ARC Sterile Radial Compression Device

RCB-0049

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: TZ Medical inc
Manufacturer SRN: US-MF-000027311
UDI-DI: 00811331011470
Basic UDI-DI: 081133101RCB-0049JG
Reference: RCB-0049
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details

ARC Sterile Radial Compression Device

RCB-0048

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: TZ Medical inc
Manufacturer SRN: US-MF-000027311
UDI-DI: 00811331011333
Basic UDI-DI: 081133101RCB-0048JE
Reference: RCB-0048
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 03:58

Manufacturer products Authorised representative products Authorised representative actors View details

BE LTA cuvette set

Thrombomate

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingSingle use

Manufacturer: Kommanditgesellschaft Behnk Elektronik GmbH & Co.
Manufacturer SRN: DE-MF-000005304
UDI-DI: +EUBE0576000%
Basic UDI-DI: ++EUBEAGGFUTBMMCT7
Reference: 057600
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 19:21

Manufacturer products View details

Platelet Aggregation Profiler, Model PAP-8E

PAP-8E

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561060771/ +$$+77XX/ 16D20200920F*
Basic UDI-DI: ++G0561060774M
Reference: 106077
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:19

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Platelet Aggregation Profiler, Model PAP-8E

Model PAP-8E

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bio/Data Corporation
Manufacturer SRN: US-MF-000026991
UDI-DI: *+G0561060751/ +$$+7XXX/ 16D20000101S*
Basic UDI-DI: ++G0561060754H
Reference: 106075
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: Italy
Authorised representative: mdi Europa GmbH
Last updated: 15.07.2026 19:19

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06958689900286

Class INot specifiedOn the marketSingle use

Manufacturer: Pujiang Jianyu Sanitary Products Co., Ltd.
Manufacturer SRN: CN-MF-000043742
UDI-DI: 06958689900286
Basic UDI-DI: 69586899TO0010001EV
Reference: N/A
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 15.07.2026 11:19

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EMOXICEL ENDO Applicator

Endoscopic applicator of haemostatic powder

Class IIaMDDOn the marketSingle useSterile

Manufacturer: BIOSTER, a.s.
Manufacturer SRN: CZ-MF-000011615
UDI-DI: D-CZMF00001161560190LM
Basic UDI-DI: B-CZMF00001161560190LM
Reference: 60190
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Czechia
Authorised representative: -
Last updated: 13.07.2026 13:40

Manufacturer products View details

Traumastem ENDO Applicator

Endoscopic applicator of haemostatic powder

Class IIaMDDOn the marketSingle useSterile

Manufacturer: BIOSTER, a.s.
Manufacturer SRN: CZ-MF-000011615
UDI-DI: D-CZMF00001161560189M4
Basic UDI-DI: B-CZMF00001161560189M4
Reference: 60189
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Czechia
Authorised representative: -
Last updated: 13.07.2026 13:40

Manufacturer products View details

Traumacel ENDO Applicator

Endoscopic applicator of haemostatic powder

Class IIaMDDOn the marketSingle useSterile

Manufacturer: BIOSTER, a.s.
Manufacturer SRN: CZ-MF-000011615
UDI-DI: D-CZMF00001161560188M2
Basic UDI-DI: B-CZMF00001161560188M2
Reference: 60188
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: Czechia
Authorised representative: -
Last updated: 13.07.2026 13:40

Manufacturer products View details

16958689900313

Class INot specifiedOn the marketSingle use

Manufacturer: Pujiang Jianyu Sanitary Products Co., Ltd.
Manufacturer SRN: CN-MF-000043742
UDI-DI: 16958689900313
Basic UDI-DI: 69586899TO0010003EZ
Reference: N/A
EMDN: W0202029085
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - CONSUMABLES
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 10.07.2026 20:19

Manufacturer products Authorised representative products Authorised representative actors View details

06975474516774

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Pro-med (Beijing) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027394
UDI-DI: 06975474516774
Basic UDI-DI: B-06975474516774
Reference: 50 tests/kit
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

06975474516767

25 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Pro-med (Beijing) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027394
UDI-DI: 06975474516767
Basic UDI-DI: B-06975474516767
Reference: 25 tests/kit
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

06975474516750

10 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Pro-med (Beijing) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027394
UDI-DI: 06975474516750
Basic UDI-DI: B-06975474516750
Reference: 10 tests/kit
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

06975474516743

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Pro-med (Beijing) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027394
UDI-DI: 06975474516743
Basic UDI-DI: B-06975474516743
Reference: 5 tests/kit
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Italy
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

06975474516736

Thrombelastograph General Cup Kit

IVD generalIVDDOn the marketKitReagentSingle use

Manufacturer: Pro-med (Beijing) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027394
UDI-DI: 06975474516736
Basic UDI-DI: B-06975474516736
Reference: 1 test/kit
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Austria
Authorised representative: Sungo Cert GmbH
Last updated: 06.07.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

High Throughput Automated Hemostasis Analyzer system

IHTEG6, IHTEG12

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Render Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032470
UDI-DI: 06976033400022
Basic UDI-DI: 697603340TE003CT
Reference: TE003
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

Hemostasis Analyzer System

ITEG2, ITEG4, ITEG6, ITEG2+, ITEG4+, ITEG6+

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

Manufacturer: Render Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032470
UDI-DI: 06976033400015
Basic UDI-DI: 697603340TE002CR
Reference: TE002
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

Hemostasis Analyzer System

IMTEG2

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

Manufacturer: Render Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032470
UDI-DI: 06976033400008
Basic UDI-DI: 697603340TE001CP
Reference: TE001
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

06975474519652

ST-1000

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Pro-med (Beijing) Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027394
UDI-DI: 06975474519652
Basic UDI-DI: 697547451WTST-10005U
Reference: ST-1000
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Belgium
Authorised representative: Sungo Cert GmbH
Last updated: 02.07.2026 19:06

Manufacturer products Authorised representative products Authorised representative actors View details