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Serotonin ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325003279
Basic UDI-DI: B-04049325003279
Reference: RE59121
EMDN: W0102039011
EMDN description: SEROTONINE
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:08

Manufacturer products View details

03770024321616

Chromogranin A New Gen. ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321616
Basic UDI-DI: B-03770024321616
Reference: 30208352
EMDN: W0102039014
EMDN description: CHROMOGRANIN A
First on market country: Germany
Authorised representative: -
Last updated: 05.07.2026 22:32

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RG-AFP

OCFA07-AFP

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321340
Basic UDI-DI: B-03770024321340
Reference: OCFA07-AFP
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:32

Manufacturer products View details

03770024321173

ELSA-NSE

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321173
Basic UDI-DI: B-03770024321173
Reference: ELSA-NSE
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

03770024321098

ELSA2-AFP

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321098
Basic UDI-DI: B-03770024321098
Reference: ELSA2-AFP
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

03770024321050

CGA-RIACT

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321050
Basic UDI-DI: B-03770024321050
Reference: CGA-RIACT
EMDN: W0102039014
EMDN description: CHROMOGRANIN A
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

03770024321074

CGA-ELISA-NG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321074
Basic UDI-DI: B-03770024321074
Reference: CGA-ELISA-NG
EMDN: W0102039014
EMDN description: CHROMOGRANIN A
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

03770024321067

CGA-ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Cisbio Bioassays
Manufacturer SRN: FR-MF-000024051
UDI-DI: 03770024321067
Basic UDI-DI: B-03770024321067
Reference: CGA-ELISA
EMDN: W0102039014
EMDN description: CHROMOGRANIN A
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:31

Manufacturer products View details

D-02B0003YF

β2-Microglobulin/Cystatin C Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0003YF
Basic UDI-DI: B-02B0003YF
Reference: 1O001
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Beta-2 Microglobulin Urine Calibrator

Beta-2 Microglobulin Urine Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021303
Basic UDI-DI: B-00816426021303
Reference: KAI-282C
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Beta-2 Microglobulin Serum/Plasma Calibrator

Beta-2 Microglobulin Serum/Plasma Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021297
Basic UDI-DI: B-00816426021297
Reference: KAI-281C
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Beta-2 Microglobulin

Beta-2 Microglobulin Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021280
Basic UDI-DI: B-00816426021280
Reference: KAI-280
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

EZ Detect Colon Disease Test

1000-1

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059100013
Basic UDI-DI: B-00083059100013
Reference: 1000-1
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:06

Manufacturer products Authorised representative products Authorised representative actors View details

EZ Detect™ Fecal Occult Blood Test Professional

1001

IVD self-testing devicesIVDDOn the marketKitNear-patient testingProfessional testingSelf testingSingle use

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059010015
Basic UDI-DI: B-00083059010015
Reference: 1001
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

EZ Detect™ Home Test for Hidden Blood in The Stool

1000

IVD self-testing devicesIVDDOn the marketKitNear-patient testingSelf testingSingle use

Manufacturer: Biomerica, Inc.
Manufacturer SRN: US-MF-000015772
UDI-DI: 00083059010008
Basic UDI-DI: B-00083059010008
Reference: 1000
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 04.07.2026 09:05

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood Test Kit (Colloidal Gold)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807195076RJ
Basic UDI-DI: B-000012807195076RJ
Reference: HWTS-OT143
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

AFP Test Kit (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: D-000012807185066R4
Basic UDI-DI: B-000012807185066R4
Reference: HWTS-OT111
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ AFP Neo

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044216
Basic UDI-DI: 880613300123BL
Reference: CFPC-156
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Greece
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:39

Manufacturer products Authorised representative products Authorised representative actors View details

ichroma™ iFOB Neo

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

Manufacturer: Boditech Med Inc.
Manufacturer SRN: KR-MF-000011028
UDI-DI: 08806133044018
Basic UDI-DI: 880613300038BU
Reference: CFPC-15-1
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Spain
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 20:38

Manufacturer products Authorised representative products Authorised representative actors View details

EasyCal® FOB

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

Manufacturer: Eurospital Spa
Manufacturer SRN: IT-MF-000028468
UDI-DI: 08028169207452
Basic UDI-DI: 802816920AW01020608042J
Reference: 9293
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 07:39

Manufacturer products View details