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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 DHEAS2 Master Curve Material (DHEAS2 MCM)

IVDR_67_TTN_DUB-C_B_REAG_DHEAS2 MCM

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414632940
Basic UDI-DI: 0405686902312V7
Reference: 11209195
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
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

Gastrin-17 Control

Low: 1×1.0 mL High: 1×1.0 mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0204T
Basic UDI-DI: B-DCC0204T
Reference: DCC020
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TSHR Control

Low: 2×2.0 mL High: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0195A
Basic UDI-DI: B-DCC0195A
Reference: DCC019
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

ACTH Control

Low: 2×2.0 mL High: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC01858
Basic UDI-DI: B-DCC01858
Reference: DCC018
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Arthritis Multi Control

Negative: 2×2.0 mL Positive: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0144Y
Basic UDI-DI: B-DCC0144Y
Reference: DCC014
EMDN: W0102152010
EMDN description: CONTROLS FOR RHEUMATOLOGY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

PG Ⅰ and PG Ⅱ Control

Low: 2×2.0 mL High: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC01756
Basic UDI-DI: B-DCC01756
Reference: DCC017
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG Control

Low: 1×1.0 mL High: 1×1.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC01552
Basic UDI-DI: B-DCC01552
Reference: DCC015
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

hs-cTnI Control

Level 1: 1×2.0 mL Level 2: 1×2.0 mL Level 3: 1×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0134W
Basic UDI-DI: B-DCC0134W
Reference: DCC013
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer Control

Low: 2×2.0 mL High: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0124U
Basic UDI-DI: B-DCC0124U
Reference: DCC012
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Autoimmune Diabetes Multi Control

Negative: 2×2.0 mL Positive: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0114S
Basic UDI-DI: B-DCC0114S
Reference: DCC011
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Celiac Disease Multi Control

Negative: 2×2.0 mL Positive: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0104Q
Basic UDI-DI: B-DCC0104Q
Reference: DCC010
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

BNP Control

Low: 2×2.0 mL High: 2×2.0 mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC00957
Basic UDI-DI: B-DCC00957
Reference: DCC009
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

ANA Control

Negative: 2×1.0 mL Positive: 2×1.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC00855
Basic UDI-DI: B-DCC00855
Reference: DCC008
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

dsDNA IgG Control

Negative: 2×1.0 mL Positive: 2×1.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC00753
Basic UDI-DI: B-DCC00753
Reference: DCC007
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Control

Low: 2×3.0 mL High: 2×3.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0064Z
Basic UDI-DI: B-DCC0064Z
Reference: DCC006
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoassay Multi Control

Level 1: 2× 3.0 mL Level 2: 2× 3.0 mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0054X
Basic UDI-DI: B-DCC0054X
Reference: DCC005
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 04.08.2026 20:26

Manufacturer products Authorised representative products Authorised representative actors View details