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85 device results listed.

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ARCHITECT

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740175634
Basic UDI-DI: 038074ARP0632PM
Reference: 06P3210
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 02:51

Manufacturer products View details

ARCHITECT

ARCHITECT NSE

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740175627
Basic UDI-DI: 038074ARP0632PM
Reference: 06P3201
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 00:03

Manufacturer products View details

00816467020327

FastPack Total PSA Calibrator 25s Kit

IVD Annex II List BIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Qualigen, Inc.
Manufacturer SRN: US-MF-000025168
UDI-DI: 00816467020327
Basic UDI-DI: B-00816467020327
Reference: 25000077
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.09.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM NSE Calibrator (NSE CAL)

IVDR_67_TTN_DUB-C_C_REAG_NSE CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414607306
Basic UDI-DI: 0405686902348VU
Reference: 11553959
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 05.08.2026 15:38

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur NSE Calibrator (NSE CAL)

IVDR_67_TTN_DUB-C_C_REAG_NSE CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414607399
Basic UDI-DI: 0405686902348VU
Reference: 11553958
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details

Beta2-microglobulin urine calibrator kit

IVD generalNot specifiedOn the market

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168004749
Basic UDI-DI: B-05415168004749
Reference: BUREK-000
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:26

Manufacturer products View details

Beta2-microglobulin calibrator kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168004015
Basic UDI-DI: B-05415168004015
Reference: B2REK-000
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Belgium
Authorised representative: -
Last updated: 02.08.2026 21:26

Manufacturer products View details

AutoLumo S100 Calibrators

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359521680
Basic UDI-DI: 697015090000133H4
Reference: CA062301
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

AutoLumo HER-2/neu CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359521642
Basic UDI-DI: 697015090000132H2
Reference: CA062201
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako DCP Calibrator Set

995-60701, 999-61201, 995-61301, 991-61401

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164475
Basic UDI-DI: 49874814987481164413UA
Reference: 999-61201
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako AFP-L3 Calibrator Set

999-60601, 997-60901, 997-61001, 993-61101

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 04987481164437
Basic UDI-DI: 49874814987481164390UP
Reference: 997-60901
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 31.07.2026 07:41

Manufacturer products Authorised representative products Authorised representative actors View details

FIT Hemoglobin NS-Prime Calibrator

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

Manufacturer: Alfresa Pharma Corporation
Manufacturer SRN: JP-MF-000008778
UDI-DI: 04987274108709
Basic UDI-DI: 4987274W0102152205HBS00XK
Reference: 910870
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S Free PSA 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: 04260157632332
Basic UDI-DI: 426015763867BFrPSAKQCXXPM
Reference: 086792N
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

B·R·A·H·M·S Free PSA KRYPTOR CAL

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

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632325
Basic UDI-DI: 426015763867BFPSAKCALXXS5
Reference: 086791N
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:37

Manufacturer products View details

B·R·A·H·M·S Total PSA KRYPTOR CAL

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

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157630741
Basic UDI-DI: 426015763810BTPSAKCALXXQB
Reference: 081091N
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:32

Manufacturer products View details

FOB-CAL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170615
Basic UDI-DI: B-08431673170615
Reference: 1107082
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:22

Manufacturer products View details

ß2-m-CAL

IVD generalIVDDOn the marketHuman tissuesProfessional testing

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673170325
Basic UDI-DI: B-08431673170325
Reference: 1107032
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 24.07.2026 00:21

Manufacturer products View details

Atellica IM Cytokeratin Fragment Calibrator 21-1 (CYFRA CAL)

IVDR_67_TTN_DUB-C_C_REAG_CYFRA CAL

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414622804
Basic UDI-DI: 0405686902360VJ
Reference: 11553957
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 22.07.2026 09:08

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Calibrator Y (CAL Y)

IVDR_67_TTN_DUB-C_C_REAG_CAL Y

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598475
Basic UDI-DI: 0405686901833VZ
Reference: 10995520
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 20.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Her-2/neu Quality Control (H2n QC)

IVDR_67_TTN_DUB-C_C_REAG_H2n QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599182
Basic UDI-DI: 0405686901854W9
Reference: 10995594
EMDN: W0102152205
EMDN description: TUMOUR MARKER STANDARDS AND CALIBRATORS
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