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SureStep CE

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Innovacon, Inc.
Manufacturer SRN: US-MF-000057104
UDI-DI: 00815845025015
Basic UDI-DI: B-00815845025015
Reference: DUE-1114-211
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 23.09.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

SureStep CE

4561669002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Innovacon, Inc.
Manufacturer SRN: US-MF-000057104
UDI-DI: 00815845025091
Basic UDI-DI: B-00815845025091
Reference: DOA-164-1641
EMDN: W0102160511
EMDN description: MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 23.09.2026 16:44

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603598

IVD generalNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603598
Basic UDI-DI: B-06926802603598
Reference: MCL02102E
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 23.09.2026 16:35

Manufacturer products Authorised representative products Authorised representative actors View details

06926802603420

IVD generalNot specifiedOn the market

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802603420
Basic UDI-DI: B-06926802603420
Reference: MCL08401E
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 23.09.2026 16:31

Manufacturer products Authorised representative products Authorised representative actors View details

06926802606940

Inflammatory Marker Controls

IVD generalIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802606940
Basic UDI-DI: B-06926802606940
Reference: MCL08801E
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 23.09.2026 16:31

Manufacturer products Authorised representative products Authorised representative actors View details

06926802605356

Total β- Human Chorionic Gonadotropin (CLIA)

IVD generalIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605356
Basic UDI-DI: B-06926802605356
Reference: MCL05801E
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 23.09.2026 16:31

Manufacturer products Authorised representative products Authorised representative actors View details

06926802605363

IVD generalIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605363
Basic UDI-DI: B-06926802605363
Reference: MCL05802E
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: R Sight B.V.
Last updated: 23.09.2026 16:31

Manufacturer products Authorised representative products Authorised representative actors View details

06926802605370

IVD generalIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802605370
Basic UDI-DI: B-06926802605370
Reference: MCL05803E
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: -
Authorised representative: R Sight B.V.
Last updated: 23.09.2026 16:31

Manufacturer products Authorised representative products Authorised representative actors View details

06926802606643

Sexual Hormone Controls

IVD generalIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802606643
Basic UDI-DI: B-06926802606643
Reference: MCL07501E
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 23.09.2026 16:30

Manufacturer products Authorised representative products Authorised representative actors View details

06926802606919

Cardiac Marker Controls

IVD generalIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802606919
Basic UDI-DI: B-06926802606919
Reference: MCL01101E
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 23.09.2026 16:30

Manufacturer products Authorised representative products Authorised representative actors View details

PD-L1 IHC 22C3 pharmDx

SK006

IVD Class CIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsHuman tissuesKitProfessional testing

Manufacturer: Agilent Technologies, Inc.
Manufacturer SRN: US-MF-000009385
UDI-DI: 05700571108239
Basic UDI-DI: 570057R0301P3007C021903N6
Reference: SK00621-2
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Denmark
Safety summary (SSCP/SSP): D67624 · Rev. 5.00
Authorised representative: Agilent Technologies Denmark ApS
Last updated: 23.09.2026 15:52

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

ARCHITECT

ARCHITECT Insulin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740169800
Basic UDI-DI: 038074ARK0841N9
Reference: 08K4103
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 14:41

Manufacturer products View details

Alinity

Alinity i Homocysteine

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740153496
Basic UDI-DI: 038074AIP0928LQ
Reference: 09P2820
EMDN: W01021307
EMDN description: HOMOCYSTEINE
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 14:41

Manufacturer products View details

Alinity

Alinity i SHBG

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740151379
Basic UDI-DI: 038074AIP0938LT
Reference: 09P3801
EMDN: W0102152208
EMDN description: STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 14:41

Manufacturer products View details

Alinity

Alinity i Insulin

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740150792
Basic UDI-DI: 038074AIT0475ML
Reference: 04T7501
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 14:41

Manufacturer products View details

Alinity

Alinity i DHEA-S

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

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740150624
Basic UDI-DI: 038074AIP0937LR
Reference: 09P3701
EMDN: W0102152202
EMDN description: HORMONE STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: -
Last updated: 23.09.2026 14:41

Manufacturer products View details

ARCHITECT

ARCHITECT Homocysteine

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: ABBOTT GmbH
Manufacturer SRN: DE-MF-000009455
UDI-DI: 00380740001223
Basic UDI-DI: 038074ARL0171MS
Reference: 01L7101
EMDN: W0102152204
EMDN description: CARDIAC MARKER STANDARDS AND CALIBRATORS
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 14:40

Manufacturer products View details

FOB Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414735727
Basic UDI-DI: 695441470234H7
Reference: IF2042
EMDN: W0102160203
EMDN description: FECAL OCCULT BLOOD - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

mAlb Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414734614
Basic UDI-DI: 695441470209H8
Reference: IF2009
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin Fast Test Kit (Immunofluorescence Assay)

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

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414729399
Basic UDI-DI: 695441479278KS
Reference: IF2139
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details