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ADVIA Centaur AMH QC Kit

IVDR_67_TTN_DUB-C_C_CDx_REAG_AMH QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414286914
Basic UDI-DI: 0405686902267VT
Reference: 11205264
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.08.2026 22:45

Manufacturer products Authorised representative products Authorised representative actors View details

Multi Control Cardiac Marker

Low value: 6 x 2 mL, high value: 6 x 2 mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341680565
Basic UDI-DI: B-06970341680565
Reference: 691028
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Multi Control Cardiac Marker

Low value: 3 x 2 mL, high value: 3 x 2 mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06970341680572
Basic UDI-DI: B-06970341680572
Reference: 691027
EMDN: W0102152004
EMDN description: CARDIAC MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 23:49

Manufacturer products Authorised representative products Authorised representative actors View details

Quality Control (25-OH-VD)

D5802Q

IVD generalIVDDOn the marketNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760296
Basic UDI-DI: B-06979469760296
Reference: D5802Q
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.08.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

Quality Control (LH)

G5802Q

IVD generalIVDDOn the marketAnimal tissuesNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469760272
Basic UDI-DI: B-06979469760272
Reference: G5802Q
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.08.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM AMH Master Curve Material (AMH MCM)

IVDR_67_TTN_DUB-C_C_CDx_REAG_AMH MCM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00842768022395
Basic UDI-DI: 0405686902268VV
Reference: 10998431
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 22:42

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur AMH Master Curve Material (AMH MCM)

IVDR_67_TTN_DUB-C_C_CDx_REAG_AMH MCM

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414225685
Basic UDI-DI: 0405686902268VV
Reference: 10998430
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 07.08.2026 02:22

Manufacturer products Authorised representative products Authorised representative actors View details

Emit II Plus Specialty Drug Control Positive

IVDR_67_GLA_DUB-C_B_REAG_Specialty Drug Controls Neg and Pos

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414601090
Basic UDI-DI: 0405686901191VC
Reference: 10718701
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 06.08.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

AESQC® IFA Negative Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510783
Basic UDI-DI: B-04250289510783
Reference: AESQCIFANEG
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 18:13

Manufacturer products View details

Aptiva® APS IgA Controls

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

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08430793040846
Basic UDI-DI: 843079304084648
Reference: 725122
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 05.08.2026 16:41

Manufacturer products Authorised representative products Authorised representative actors View details

APS Multi Control

Level 1:2x2.0 mL Level 2:2x2.0 mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC02555
Basic UDI-DI: B-DCC02555
Reference: DCC025
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 15:27

Manufacturer products Authorised representative products Authorised representative actors View details

Thrombosis Marker Multi Control

Low: 2×2.0 mL High: 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-DCC0234Z
Basic UDI-DI: B-DCC0234Z
Reference: DCC023
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 15:27

Manufacturer products Authorised representative products Authorised representative actors View details

ENA 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-DCC0224X
Basic UDI-DI: B-DCC0224X
Reference: DCC022
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 15:27

Manufacturer products Authorised representative products Authorised representative actors View details

Calcitonin Control

Low: 1×1.0 mL High: 1×1.0 mL

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DCC0214V
Basic UDI-DI: B-DCC0214V
Reference: DCC021
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 05.08.2026 15:27

Manufacturer products Authorised representative products Authorised representative actors View details

Multiparametric controls H

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168007351
Basic UDI-DI: B-05415168007351
Reference: MPCOX-005
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Belgium
Authorised representative: -
Last updated: 05.08.2026 13:47

Manufacturer products View details

Multiparametric controls M

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Diagam S.A.
Manufacturer SRN: BE-MF-000022993
UDI-DI: 05415168007344
Basic UDI-DI: B-05415168007344
Reference: MPCON-005
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Belgium
Authorised representative: -
Last updated: 05.08.2026 13:47

Manufacturer products View details

IDS ANA Control Set

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169693883
Basic UDI-DI: B-05060169693883
Reference: IS-AI1130
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 05.08.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

IDS-iSYS Direct Renin Control Set

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690394
Basic UDI-DI: B-05060169690394
Reference: IS-3430
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 05.08.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

AESQC® ANA HEp-2 Nucleolar

AESQC® ANA HEp-2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510943
Basic UDI-DI: B-04250289510943
Reference: AESQCANA09
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:58

Manufacturer products View details

AESQC® ANA HEp-2 Panel 1

AESQC® ANA HEp-2

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510844
Basic UDI-DI: B-04250289510844
Reference: AESQCIFANAP1
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:58

Manufacturer products View details