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51 device results listed.

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ST2 Calibrators

105-038094-00, 105-038095-00, 105-038096-00, 105-040606-00, 105-040605-00, 105-040608-00, 105-040607-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053045971
Basic UDI-DI: 69449040AB74000515M
Reference: 105-038096-00
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Calibrators

105-028988-00、105-028989-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053039017
Basic UDI-DI: 69449040AB74000235G
Reference: 105-031858-00
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:49

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S Copeptin proAVP 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: 04260157632301
Basic UDI-DI: 426015763857BCpAVKCALXXA4
Reference: 085791N
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

Dimension Mass Creatine Kinase MB Isoenzyme Calibrator

IVDR_67_GLA_DUB-C_C_REAG_MMB CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013706
Basic UDI-DI: 0405686901281VE
Reference: 10445023
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:43

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI High Sensitivity Troponin I Calibrator

IVDR_67_GLA_DUB-C_C_REAG_TNIH_Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414180380
Basic UDI-DI: 0405686900217UW
Reference: 10719483
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 23.07.2026 22:40

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Calibrator U (CAL U)

IVDR_67_TTN_DUB-C_C_REAG_CAL U

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598468
Basic UDI-DI: 0405686900814VN
Reference: 10995519
EMDN: W0102152204
EMDN description: CARDIAC 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

Dimension CardioPhase high sensitivity C-reactive protein Calibrator

IVDR_67_GLA_DUB-C_C_REAG_CCRP CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016011
Basic UDI-DI: 0405686901078VF
Reference: 10445003
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Homocysteine Calibrator (HCY CAL)

IVDR_67_TTN_DUB-C_B_REAG_HCY Cal

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598253
Basic UDI-DI: 0405686901719W2
Reference: 10995498
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:14

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Creatine Kinase MB Calibrator (CKMB CAL)

IVDR_67_TTN_DUB-C_C_REAG_CKMB Calibrator

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598598
Basic UDI-DI: 0405686901905VZ
Reference: 10995532
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:35

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI N-terminal Pro-Brain Natriuretic Peptide calibrator

IVDR_67_GLA_DUB-C_C_REAG_LOCI NTP CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768026324
Basic UDI-DI: 0405686901276VM
Reference: 10464529
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Myoglobin Calibrator

IVDR_67_GLA_DUB-C_C_REAG_MYO CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768013720
Basic UDI-DI: 0405686901285VN
Reference: 10445024
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM B‑Type Natriuretic Peptide Calibrator (BNP CAL)

IVDR_67_TTN_DUB-C_C_REAG_BNP_Cal

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598000
Basic UDI-DI: 0405686900812VJ
Reference: 10995473
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01822117H

CK & CK-MB Calibrator

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01822117H
Basic UDI-DI: B-ECH01822117H
Reference: ECH0182211
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:39

Manufacturer products Authorised representative products Authorised representative actors View details

D-ECH01812117A

CK & CK-MB Calibrator

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-ECH01812117A
Basic UDI-DI: B-ECH01812117A
Reference: ECH0181211
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:38

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® B2GP1 IgG Controls

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950595250
Basic UDI-DI: B-08426950595250
Reference: 701247
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash

QUANTA Flash® B2GP1 IgM Controls

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950595038
Basic UDI-DI: B-08426950595038
Reference: 701252
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:20

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101981

1.0 mL/ vial, 4 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101981
Basic UDI-DI: B-06974671101981
Reference: DR-CAL-CK-A031
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101967

1.0 mL/ vial, 4 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101967
Basic UDI-DI: B-06974671101967
Reference: DR-CAL-CK-A030
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101943

1.0 mL/ vial, 4 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101943
Basic UDI-DI: B-06974671101943
Reference: DR-CAL-CK-A029
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details

06974671101929

1.0 mL/ vial, 4 vials

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Darui Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000030310
UDI-DI: 06974671101929
Basic UDI-DI: B-06974671101929
Reference: DR-CAL-CK-A028
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:10

Manufacturer products Authorised representative products Authorised representative actors View details