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T3 Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Heavybio,Inc
Manufacturer SRN: CN-MF-000049958
UDI-DI: D-HP123UM
Basic UDI-DI: B-HP123UM
Reference: HP123-1F, HP123-2F
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Heavybio,Inc
Manufacturer SRN: CN-MF-000049958
UDI-DI: D-HP106UM
Basic UDI-DI: B-HP106UM
Reference: HP106-1F,HP106-2F
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Heavybio,Inc
Manufacturer SRN: CN-MF-000049958
UDI-DI: D-HP103UF
Basic UDI-DI: B-HP103UF
Reference: HP103-2F, HP103-3F
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:57

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HEV IgG (Liquid) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-HEVIgGCONZU
Basic UDI-DI: B-HEVIgGCONZU
Reference: HEV IgG CON
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM (Liquid) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-HAVIgMCONYS
Basic UDI-DI: B-HAVIgMCONYS
Reference: HAV IgM CON
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:52

Manufacturer products Authorised representative products Authorised representative actors View details

HAV Ab (Liquid) Control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-HAVAbCONV9
Basic UDI-DI: B-HAVAbCONV9
Reference: HAV Ab CON
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:52

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood Control Kit

GEFOB-PN2

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GEFOB-PN2HG8H
Basic UDI-DI: B-GEFOB-PN2HG8H
Reference: GEFOB-PN2
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:35

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Dimension Vista PROT1 CON M

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006340
Basic UDI-DI: 0405686900923VU
Reference: 10445920
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 23:13

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Dimension Vista PROT1 CON H

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006357
Basic UDI-DI: 0405686900923VU
Reference: 10445921
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 23:13

Manufacturer products View details

Dimension Vista PROT2 CON H

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006487
Basic UDI-DI: 0405686900925VY
Reference: 10445937
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 23:13

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Atellica IM Intact Parathyroid Hormone Master Curve Material (PTH MCM)

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599489
Basic UDI-DI: 0405686901765W9
Reference: 10995625
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:59

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Atellica IM BRAHMS Procalcitonin Quality Control (PCT QC)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414246567
Basic UDI-DI: 0405686901862W8
Reference: 11202700
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 13.07.2026 22:57

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T4 Control

FKTT4-PN20