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77 device results listed.

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ROTEM® sigma

211000

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

Manufacturer: Tem Innovations GmbH
Manufacturer SRN: DE-MF-000012176
UDI-DI: 04260160470372
Basic UDI-DI: 4260160470372RT
Reference: 211000
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:39

Manufacturer products View details

ROTEM® delta

200100

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

Manufacturer: Tem Innovations GmbH
Manufacturer SRN: DE-MF-000012176
UDI-DI: 04260160470020
Basic UDI-DI: 4260160470020QR
Reference: 200100
EMDN: W0202029001
EMDN description: THROMBELASTOGRAPHS
First on market country: Austria
Authorised representative: -
Last updated: 31.07.2026 01:39

Manufacturer products View details

UniTip Applicator

UniTip applicator

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: H. + H. Maslanka Chirurgische Instrumente GmbH
Manufacturer SRN: DE-MF-000005600
UDI-DI: 04251121113650
Basic UDI-DI: 42511211TD14BJ
Reference: ESA010146-38 (UT0038)
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 00:52

Manufacturer products View details

ST Genesia®

Automatic Analyzer

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450868142
Basic UDI-DI: 3607450INST0007UR
Reference: 86814
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

sthemO 201

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450590326
Basic UDI-DI: 3607450INST0001UD
Reference: 59032
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

sthemO 301

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450590180
Basic UDI-DI: 3607450INST0002UF
Reference: 59018
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

STA R Max® 2

STA R Max

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450589924
Basic UDI-DI: 3607450INST0004UK
Reference: 58992
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

STA Compact Max® 2

STA Compact Max

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450589894
Basic UDI-DI: 3607450INST0003UH
Reference: 58989
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

STA Satellite Max®

STA Satellite Max

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 03607450580303
Basic UDI-DI: 3607450INST0005UM
Reference: 58030
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:11

Manufacturer products View details

Quantra Hemostasis Analyzer

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

Manufacturer: Hemosonics LLC
Manufacturer SRN: US-MF-000034476
UDI-DI: 00850003761008
Basic UDI-DI: 08500037610001CX
Reference: HS-001
EMDN: W0202029099
EMDN description: VARIOUS HEMOSTASIS INSTRUMENTS - OTHER
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 06:04

Manufacturer products Authorised representative products Authorised representative actors 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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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

Manufacturer products Authorised representative products Authorised representative actors View details

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