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312 device results listed.

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tIgE Control

CL-series machine

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053077521
Basic UDI-DI: 69449040AB74000535R
Reference: tIgE Control
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoassay Multi Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912738947
Basic UDI-DI: 692591270139HH
Reference: CC817
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

i-Track 10 Cartridge Check System

IS-6010

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

Manufacturer: Immunodiagnostic Systems SA
Manufacturer SRN: BE-MF-000015341
UDI-DI: 05425030420034
Basic UDI-DI: 5425030426012S5
Reference: TD IS-6010
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 11:04

Manufacturer products View details

SERUM BONE MARKER LEVEL 1 CONTROL (SERUM BONE MARKER CONTROL 1)

SERUM BONE MARKER CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219098
Basic UDI-DI: 50552732BSUBOMK154TC
Reference: SBM10574
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:13

Manufacturer products View details

LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3)

LIPOPROTEIN (a) CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273204445
Basic UDI-DI: 50552732BLIPCON082K4
Reference: LP3406
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Northern Ireland
Authorised representative: -
Last updated: 31.07.2026 08:11

Manufacturer products View details

B·R·A·H·M·S MR-proADM II KRYPTOR QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157638495
Basic UDI-DI: 426015763847BADMIIKQCXXF5
Reference: 084792N
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:35

Manufacturer products View details

B·R·A·H·M·S sFlt-1 KRYPTOR QC

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632486
Basic UDI-DI: 426015763845BsFlt1KQCXXHH
Reference: 084592N
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

B·R·A·H·M·S Inhibin A KRYPTOR QC

IVD Class CIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632417
Basic UDI-DI: 426015763850BInhiAKQCXX2H
Reference: 085092N
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

B·R·A·H·M·S MR-proADM KRYPTOR QC

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631540
Basic UDI-DI: 426015763829BMRpADKQCXXFF
Reference: 082992N
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:33

Manufacturer products View details

B·R·A·H·M·S PCT sensitive KRYPTOR QC

IVD Class CIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631465
Basic UDI-DI: 426015763825BPCTseKQCXXQD
Reference: 082592N
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:33

Manufacturer products View details

B·R·A·H·M·S uE3 KRYPTOR CAL

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157630628
Basic UDI-DI: 426015763803BuE3KCAL0XXR5
Reference: 080391N
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

Manufacturer products View details

Access PAPP-A QC

A48573

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

Manufacturer: IMMUNOTECH SAS
Manufacturer SRN: FR-MF-000011121
UDI-DI: 15099590204020
Basic UDI-DI: 150995903AccPAPPAQCXE
Reference: A48573
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:42

Manufacturer products View details

Access Ostase QC

37309

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232290
Basic UDI-DI: 150995901AccOstQCXR
Reference: 37309
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Access SHBG QC

A48619

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590204051
Basic UDI-DI: 150995901AccSHBGQC3V
Reference: A48619
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Access Inhibin A (QC)

A36100

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590203061
Basic UDI-DI: 150995901AccInhAQCHF
Reference: A36100
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

Access IL-6 (Quality Control)

A16371

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201876
Basic UDI-DI: 150995901AccIL6QCDH
Reference: A16371
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

IgE-CONTROL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170530
Basic UDI-DI: B-08431673170530
Reference: 1107053
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:22

Manufacturer products View details

LIAISON® Control tTG IgA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771200899
Basic UDI-DI: B-08056771200899
Reference: 310321
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:40

Manufacturer products View details

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