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254 device results listed.

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SAA Control

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762841
Basic UDI-DI: 697134876229C284148
Reference: MF-229
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 07:38

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE C-Reactive Protein Control Module

IVDR_67_LLB_DUB-C_C_REAG_C-Reactive Protein Con Module

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414953144
Basic UDI-DI: 0405686900354V9
Reference: 10385316
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® Control Cardiolipin IgM

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100540
Basic UDI-DI: B-08056771100540
Reference: 310381
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 22:31

Manufacturer products View details

LIAISON® Control Cardiolipin IgG

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100526
Basic UDI-DI: B-08056771100526
Reference: 310371
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 22:31

Manufacturer products View details

K-ASSAY Apo AII / CII / CIII / E Control

Apo AII / CII / CIII / E Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021662
Basic UDI-DI: B-00816426021662
Reference: K315C-4M
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 16.07.2026 13:33

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Apo AI/B Control

Apo AI/B Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021648
Basic UDI-DI: B-00816426021648
Reference: K310C-4M
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 16.07.2026 13:33

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Beta-2 Microglobulin/Ferritin - Serum/Plasma Control

Beta-2 Microglobulin / Ferritin - Serum / Plasma Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021327
Basic UDI-DI: B-00816426021327
Reference: K283C-4M
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 16.07.2026 13:33

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST B･R･A･H･M･S PCT Control

PATHFAST B·R·A·H·M·S PCT Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595302107
Basic UDI-DI: 4987595PF0221CWJ
Reference: 30210
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7022C · Rev. 6
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST Presepsin Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595302008
Basic UDI-DI: 4987595PF0201CW8
Reference: 30200
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7020C · Rev. 6
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

DNlite uPTM-FetA ELISA Kit - Controls

8105001

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Bio Preventive Medicine Corp.
Manufacturer SRN: TW-MF-000022845
UDI-DI: 04719879495003
Basic UDI-DI: 471987949E103047Q
Reference: 8105001
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM VitDII Quality Control (VitDII QC)

IVDR_67_TTN_DUB-C_B_REAG_KIT_VitDII QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414649887
Basic UDI-DI: 0405686902371VP
Reference: 11698632
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE PAP Control Module

IVDR_67_LLB_DUB-C_C_REAG_PAP Control Module

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414996639
Basic UDI-DI: 0405686901483VU
Reference: 10385588
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE D-Dimer Control Module

IVDR_67_LLB_DUB-C_C_REAG_D-Dimer Control Module