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209 device results listed.

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03661540301483

OA-010

IVD generalIVDDOn the marketKit

Manufacturer: ELITechGroup Inc.
Manufacturer SRN: US-MF-000006942
UDI-DI: 03661540301483
Basic UDI-DI: B-03661540301483
Reference: OA-010
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 05.07.2026 17:16

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva® Optical Calibrator Kit

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

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793041126
Basic UDI-DI: 843079304112636
Reference: AC1001
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:26

Manufacturer products Authorised representative products Authorised representative actors View details

Calibration Standard Solution

TS I 、TS II

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873820198
Basic UDI-DI: 697287382TS74
Reference: /
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 02.07.2026 13:18

Manufacturer products Authorised representative products Authorised representative actors View details

Ketone Body Calibrator 300

993-73791

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164823
Basic UDI-DI: 498748114987481164823ZS
Reference: 993-73791
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 02.07.2026 01:07

Manufacturer products Authorised representative products Authorised representative actors View details

Tuning solution for the analyte

Accessories for 1,25-(OH)2-Vitamin D3/D2 LC-MS/MS product variants

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598011991
Basic UDI-DI: 4050598LCACVITQV
Reference: KM1000TU
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 19:16

Manufacturer products View details

Tuning solution for the analyte

Accessories for Hepcidin-25 LC-MS/MS

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598011946
Basic UDI-DI: 4050598LCACFELX
Reference: KM4000TU
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 19:16

Manufacturer products View details

System Calibrator

66300

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

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590131180
Basic UDI-DI: 15099590266300SS
Reference: 66300
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 11:45

Manufacturer products View details

Urine Calibrator

B64606

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

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590080990
Basic UDI-DI: 150995902B64606SA
Reference: B64606
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 11:45

Manufacturer products View details

Bicarbonate Calibrator

ODC0019

IVD Class BIVDR 2017/746On the marketKitProfessional testing

Manufacturer: Beckman Coulter Ireland Inc.
Manufacturer SRN: IE-MF-000000887
UDI-DI: 15099590070441
Basic UDI-DI: 150995902ODC001994
Reference: ODC0019
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Ireland
Authorised representative: -
Last updated: 01.07.2026 11:45

Manufacturer products View details

Access CK-MB Calibrators

386372

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232412
Basic UDI-DI: 150995901AccCKMBCalS5
Reference: 386372
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:38

Manufacturer products Authorised representative products Authorised representative actors View details

ReferrIL HbA1c

HbA1c

IVD Class CIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Instrumentation Laboratory SpA
Manufacturer SRN: IT-MF-000009277
UDI-DI: 08426951410828
Basic UDI-DI: 84307930553384W
Reference: 0018167400
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 15:25

Manufacturer products View details

06970256840481

115mm*125mm

Class IMDR 2017/745On the marketDirect markingSingle use

Manufacturer: Anqing YIPAK Packaging Material Co., Ltd.
Manufacturer SRN: CN-MF-000025130
UDI-DI: 06970256840481
Basic UDI-DI: 69702568400138G
Reference: 115mm*125mm
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Spain
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 30.06.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Hemoglobin (A2/F/A1c) Calibrator Kit

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384631043
Basic UDI-DI: B-06938384631043
Reference: L-500309
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.06.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Calibrator Kit

IVD generalNot specifiedOn the market

Manufacturer: Labnovation Technologies, Inc.
Manufacturer SRN: CN-MF-000015953
UDI-DI: 06938384631029
Basic UDI-DI: B-06938384631029
Reference: L-500301
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.06.2026 00:42

Manufacturer products Authorised representative products Authorised representative actors View details

Neonatal Phenylalanine Controls

IVD Annex II List BNot specifiedOn the market

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172194021
Basic UDI-DI: B-06438172194021
Reference: 6190930
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:40

Manufacturer products View details

Neonatal Phenylalanine Calibrators

IVD Annex II List BNot specifiedOn the market

Manufacturer: Labsystems Diagnostics Oy
Manufacturer SRN: FI-MF-000018281
UDI-DI: 06438172194014
Basic UDI-DI: B-06438172194014
Reference: 6190940
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:40

Manufacturer products View details

LAMBDA FREE LIGHT CHAINS CALIBRATOR

IVD Class BNot specifiedOn the market

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309174898
Basic UDI-DI: 5204309000057P7
Reference: 1478-0665
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 20.06.2026 03:21

Manufacturer products View details

KAPPA FREE LIGHT CHAINS CALIBRATOR

IVD Class BNot specifiedOn the market

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309174881
Basic UDI-DI: 5204309000056P5
Reference: 1478-0655
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: Greece
Authorised representative: -
Last updated: 20.06.2026 03:21

Manufacturer products View details

Calibration Standard Solution

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Cornley Bio-Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000017322
UDI-DI: 06972873820204
Basic UDI-DI: 697287382TS74
Reference: /
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: -
Authorised representative: Umedwings Netherlands B.V.
Last updated: 16.06.2026 13:30

Manufacturer products Authorised representative products Authorised representative actors View details

Wash plate

IVD Class AIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598012066
Basic UDI-DI: 4050598LCACVITQV
Reference: -
EMDN: W0101050399
EMDN description: CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER
First on market country: -
Authorised representative: -
Last updated: 14.06.2026 16:10

Manufacturer products View details