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392 device results listed.

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DxPG80.Lab

DxPG80

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Progastrin Manufacturing
Manufacturer SRN: FR-MF-000011162
UDI-DI: 03760314550048
Basic UDI-DI: 37603145500798
Reference: DxL2
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 15:24

Manufacturer products View details

HbA1c Advanced

B93009

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590012120
Basic UDI-DI: 150995901B93009RT
Reference: B93009
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:34

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c

B00389

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590012052
Basic UDI-DI: 150995901B00389PA
Reference: B00389
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:34

Manufacturer products Authorised representative products Authorised representative actors View details

DxPG80.Lab

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Progastrin Manufacturing
Manufacturer SRN: FR-MF-000011162
UDI-DI: 03760314550055
Basic UDI-DI: 37603145500798
Reference: DxL4
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: -
Authorised representative: -
Last updated: 29.06.2026 09:00

Manufacturer products View details

06956013911083

1 piece/bag, 25 pieces/box.

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: AVE Science & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000031214
UDI-DI: 06956013911083
Basic UDI-DI: B-06956013911083
Reference: --
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin (β2-MG) Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819578
Basic UDI-DI: B-06950334819578
Reference: 32027170
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

S100-β Determination Kit（Fluorescence Immunochromatography Assay）

25 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580590
Basic UDI-DI: 697518250P1150165
Reference: P11501
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:23

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200946
Basic UDI-DI: B-06942202200946
Reference: 3018580
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200939
Basic UDI-DI: B-06942202200939
Reference: 3018622
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200922
Basic UDI-DI: B-06942202200922
Reference: 3018582
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:50

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200915
Basic UDI-DI: B-06942202200915
Reference: 3018570
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200588
Basic UDI-DI: B-06942202200588
Reference: 3018456
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200571
Basic UDI-DI: B-06942202200571
Reference: 3018469
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200564
Basic UDI-DI: B-06942202200564
Reference: 3018454
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200557
Basic UDI-DI: B-06942202200557
Reference: 3018451
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

06941967223504

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967223504
Basic UDI-DI: B-06941967223504
Reference: 01.09.07.02.EC.01
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

Myxovirus Resistance Protein A Test Kit (FIA)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339210395
Basic UDI-DI: B-06937339210395
Reference: VID137-01-011
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:58

Manufacturer products Authorised representative products Authorised representative actors View details

MxA/CRP Test Kit (FIA)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339209177
Basic UDI-DI: B-06937339209177
Reference: VID221-01-011
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.06.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

06937287300261

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300261
Basic UDI-DI: B-06937287300261
Reference: R1: 2×60 mL, R2: 2×15 mL
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:51

Manufacturer products Authorised representative products Authorised representative actors View details

Heparin binding protein Kit (Latex-Enhanced Immunoturbidimetric Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595752106
Basic UDI-DI: B-06936595752106
Reference: MJ036Y
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details