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Emit II Plus Specialty Drug Calibrator / Control Level 4

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601168
Basic UDI-DI: 0405686901190VA
Reference: 10720052
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 04.08.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

Folate Calibrators

105-008683-00、105-008688-00、105-008551-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904091266
Basic UDI-DI: 69449040004L-Folate****KD
Reference: 105-008551-00
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

Calcitonin Calibrators

105-008685-00、105-008690-00、105-008550-00

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

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904091259
Basic UDI-DI: 69449040004L-CT********LY
Reference: 105-008550-00
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 04.08.2026 22:08

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin Calibration Set

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153000799
Basic UDI-DI: 6438153BU00121BE
Reference: 981874
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Finland
Authorised representative: -
Last updated: 04.08.2026 21:59

Manufacturer products View details

Atellica IM aTPOII Master Curve Material (aTPOII MCM)

IVDR_67_TTN_DUB-C_B_REAG_aTPOII MCM

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414608778
Basic UDI-DI: 0405686902271VJ
Reference: 11203694
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
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

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

Atellica IM Anti-CCP IgG Master Curve Material (aCCP MCM)

IVDR_67_TTN_DUB-C_B_REAG_aCCP_MCM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414245683
Basic UDI-DI: 0405686900756VZ
Reference: 10733000
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN 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

Atellica CH Cystatin C_2 Calibrators (CYSC_2 CAL)

IVDR_67_TTN_DUB-C_C_REAG_CYSC_2 CAL

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414238104
Basic UDI-DI: 0405686901846WA
Reference: 11097648
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN 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

CALIBRADOR DE APOLIPOPROTEINAS

CALIBRADOR DE APOLIPOPROTEÍNAS

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155009013
Basic UDI-DI: B-18430155009013
Reference: 993690
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Spain
Authorised representative: -
Last updated: 04.08.2026 18:48

Manufacturer products View details

Aptiva

Aptiva® Celiac Disease IgG Calibrators

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040518
Basic UDI-DI: B-08430793040518
Reference: 724101
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Aptiva

Aptiva® CTD Essential Calibrators

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040181
Basic UDI-DI: B-08430793040181
Reference: 723101
EMDN: W0102152211
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 04.08.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein Calibrator

1×0.5mL（Calibrator 1）

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493097167
Basic UDI-DI: B-06970493097167
Reference: MY-0002-01
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 03.08.2026 23:59

Manufacturer products Authorised representative products Authorised representative actors View details

DIRUI

Type A：Low value：1×0.5mL, High value：1×0.5mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223334
Basic UDI-DI: B-06942202223334
Reference: Type A：Low value：1×0.5mL, High value：1×0.5mL
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin Calibrator

Type B：5×1mL（5levels）

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223280
Basic UDI-DI: B-06942202223280
Reference: 3024317
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin Calibrator

Type B：5×0.5mL（5levels）

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223273
Basic UDI-DI: B-06942202223273
Reference: 3024318
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

β2-Microglobulin Calibrator

Type A：5×1mL（5levels）

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202223266
Basic UDI-DI: B-06942202223266
Reference: 3024273
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 03.08.2026 16:49

Manufacturer products Authorised representative products Authorised representative actors View details

CORMAY MICROALBUMIN CALIBRATOR

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514651931
Basic UDI-DI: B-05907514651931
Reference: 5-193
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:09

Manufacturer products View details

CORMAY FERRITIN CALIBRATORS

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514644919
Basic UDI-DI: B-05907514644919
Reference: 4-491
EMDN: W0102152206
EMDN description: ANAEMIA RELATED/VITAMIN STANDARDS AND CALIBRATORS
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:07

Manufacturer products View details

CORMAY IMMUNO-MULTICAL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514642878
Basic UDI-DI: B-05907514642878
Reference: 4-287
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:05

Manufacturer products View details

CORMAY Lp (a) CALIBRATORS

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: PZ CORMAY Spółka Akcyjna
Manufacturer SRN: PL-MF-000023053
UDI-DI: 05907514642816
Basic UDI-DI: B-05907514642816
Reference: 4-281
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Poland
Authorised representative: -
Last updated: 03.08.2026 01:05

Manufacturer products View details