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183 device results listed.

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ADVIA Centaur Calibrator G (CAL G)

IVDR_67_TTN_DUB-C_C_REAG_Calibrator G

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414182254
Basic UDI-DI: 0405686901836W7
Reference: 10337270
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Insulin Calibrator (IRI CAL)

IVDR_67_TTN_DUB-C_B_REAG_IRI_Cal

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600451
Basic UDI-DI: 0405686900790VZ
Reference: 10995629
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 05:15

Manufacturer products Authorised representative products Authorised representative actors View details

Immunochemistry Systems CAL 2 Calibrator 2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-663940RM
Basic UDI-DI: B-663940RM
Reference: 663940
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 17.07.2026 03:46

Manufacturer products Authorised representative products Authorised representative actors View details

DNlite uPTM-FetA ELISA Kit – Standard

8105002

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Bio Preventive Medicine Corp.
Manufacturer SRN: TW-MF-000022845
UDI-DI: 04719879495010
Basic UDI-DI: 471987949E103057S
Reference: 8105002
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - 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 CH Protein 2 Calibrator (PROT2 CAL)

IVDR_67_TTN_DUB-C_C_REAG_PROT2 CAL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414611051
Basic UDI-DI: 0405686902331VB
Reference: 11537246
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica CH Toxicology Calibrator (TOX CAL)

IVDR_67_TTN_DUB-C_B_REAG_TOX CAL

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597614
Basic UDI-DI: 0405686901780W5
Reference: 11099440
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
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

ADVIA Centaur Calibrator E

IVDR_67_TTN_DUB-C_B_REAG_CAL E

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414524719
Basic UDI-DI: 0405686901677WB
Reference: 10309079
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® Calibrator B

IVDR_67_TTN_DUB-C_C_REAG_Cal B

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414504797
Basic UDI-DI: 0405686901830VT
Reference: 10308986
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® H2n Calibrator

IVDR_67_TTN_DUB-C_C_REAG_H2n Cal

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414471228
Basic UDI-DI: 0405686901853W7
Reference: 10308993
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator Q (CAL Q)

IVDR_67_TTN_DUB-C_C_REAG_CAL Q

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414202921
Basic UDI-DI: 0405686901832VX
Reference: 10310296
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator C (CAL C)

IVDR_67_TTN_DUB-C_B_REAG_CAL C

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414124919
Basic UDI-DI: 0405686901676W9
Reference: 10311575
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator A (CAL A)

IVDR_67_TTN_DUB-C_B_REAG_CAL A

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414555324
Basic UDI-DI: 0405686900774W3
Reference: 10285904
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur 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: 00630414178493
Basic UDI-DI: 0405686900814VN
Reference: 10309996
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:12

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Calibrator Q (CAL Q)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598444
Basic UDI-DI: 0405686901832VX
Reference: 10995517
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Calibrator Q (CAL Q)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414202938
Basic UDI-DI: 0405686901832VX
Reference: 10310295
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Calibrator B (CAL B)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598307
Basic UDI-DI: 0405686901830VT
Reference: 10995503
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Calibrator Q (CAL Q)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598451
Basic UDI-DI: 0405686901832VX
Reference: 10995518
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Calibrator B (CAL B)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598314
Basic UDI-DI: 0405686901830VT
Reference: 10995504
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 14.07.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4283057HY

Anti-thyroid peroxidase antibodies (Anti-TPO) Calibrators (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283057HY
Basic UDI-DI: B-EIM4283057HY
Reference: EIM4283057
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4283056HW

Anti-thyroglobulin antibodies (Anti-TG) Calibrators (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4283056HW
Basic UDI-DI: B-EIM4283056HW
Reference: EIM4283056
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:55

Manufacturer products Authorised representative products Authorised representative actors View details