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560 device results listed.

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IDK® EDN ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598168114
Basic UDI-DI: B-04050598168114
Reference: K 6811
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

IDK® S100A12 ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598169388
Basic UDI-DI: B-04050598169388
Reference: K 6938
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

UltraCE Serum Protein

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013025689
Basic UDI-DI: 505601300ULTCESPE6
Reference: V8100
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: France
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

SAS-MX SP-10 Kit

Serum Protein Kits

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Helena Biosciences Europe
Manufacturer SRN: GB-MF-000028365
UDI-DI: 05056013007944
Basic UDI-DI: 5056013005BANDM8
Reference: 100100
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Northern Ireland
Authorised representative: Advena Limited
Last updated: 31.07.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors View details

DNlite-IVD103

DNlite uPTM-FetA ELISA Kit

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

Manufacturer: Bio Preventive Medicine Corp.
Manufacturer SRN: TW-MF-000022845
UDI-DI: 04719879490664
Basic UDI-DI: 471987949E103017J
Reference: 8103106 (4oC)
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

DNlite-IVD103

DNlite uPTM-FetA ELISA Kit

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

Manufacturer: Bio Preventive Medicine Corp.
Manufacturer SRN: TW-MF-000022845
UDI-DI: 04719879490053
Basic UDI-DI: 471987949E103017J
Reference: 8103106 (-20oC)
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Czechia
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590224028
Basic UDI-DI: 150995901447750LP
Reference: 447750
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Latex

OSR6299

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590020392
Basic UDI-DI: 150995901OSR6299N5
Reference: OSR6299
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin

OSR61203

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590011901
Basic UDI-DI: 150995901OSR61203SK
Reference: OSR61203
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Latex

OSR6199

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010959
Basic UDI-DI: 150995901OSR6199MY
Reference: OSR6199
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Streptolysin O (ASO)

OSR6194

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010904
Basic UDI-DI: 150995901OSR6194MN
Reference: OSR6194
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Myoglobin

OSR6168

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

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590010652
Basic UDI-DI: 150995902OSR6168N8
Reference: OSR6168
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:28

Manufacturer products View details

a-1-ANTITRYPSIN

OSR6163

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590010607
Basic UDI-DI: 150995902OSR6163MW
Reference: OSR6163
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 30.07.2026 20:28

Manufacturer products View details

β-2 Microglobulin (β-2 M)

OSR6151

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010485
Basic UDI-DI: 150995901OSR6151M4
Reference: OSR6151
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

CRP

OSR6147

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590010447
Basic UDI-DI: 150995901OSR6147MD
Reference: OSR6147
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-DIMER

OSR60135

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590000332
Basic UDI-DI: 150995901OSR60135SL
Reference: OSR60135
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

BCA-225 [Cu-18]

ACI3241B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627024831
Basic UDI-DI: B-00847627024831
Reference: ACI3241B
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Spain
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

BCA-225 [Cu-18]

ACI3241A

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627024824
Basic UDI-DI: B-00847627024824
Reference: ACI3241A
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Latvia
Authorised representative: Emergo Europe B.V.
Last updated: 29.07.2026 23:15

Manufacturer products Authorised representative products Authorised representative actors View details

ALK [5A4]

ACI3041B

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627002754
Basic UDI-DI: B-00847627002754
Reference: ACI3041B
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.07.2026 12:58

Manufacturer products Authorised representative products Authorised representative actors View details

AMACR (RM)

OPAI3024T60

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627031167
Basic UDI-DI: B-00847627031167
Reference: OPAI3024T60
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Bulgaria
Authorised representative: Emergo Europe B.V.
Last updated: 25.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details