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OC-Light™ S FIT Test Strips

OC-Light™ S FIT Test Strips

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04987026207339
Basic UDI-DI: 4987026TD-OCLSZW
Reference: V-PC52
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Italy
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

OC-SENSOR FIT Buffer (for OC-SENSOR io, Micro)

OC-SENSOR Reagent Family

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: EIKEN CHEMICAL CO., LTD.
Manufacturer SRN: JP-MF-000018097
UDI-DI: 04987026117294
Basic UDI-DI: 4987026TD-OCHBYG
Reference: V-PH46
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Germany
Authorised representative: Advena Limited
Last updated: 31.07.2026 07:31

Manufacturer products Authorised representative products Authorised representative actors View details

B·R·A·H·M·S CgA II KRYPTOR

B·R·A·H·M·S CgA II KRYPTOR

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

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157632127
Basic UDI-DI: 426015763839BCgAIIK00XXNL
Reference: 839050N
EMDN: W0102039014
EMDN description: CHROMOGRANIN A
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

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B·R·A·H·M·S NSE KRYPTOR

B·R·A·H·M·S NSE KRYPTOR

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

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631984
Basic UDI-DI: 426015763821BNSEK0000XXTW
Reference: 821050N
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

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B·R·A·H·M·S AFP KRYPTOR

B·R·A·H·M·S AFP KRYPTOR

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: B·R·A·H·M·S GmbH
Manufacturer SRN: DE-MF-000026030
UDI-DI: 04260157631946
Basic UDI-DI: 426015763816BAFPK0000XXHT
Reference: 816075N
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 01:34

Manufacturer products View details

VIDAS® AFP

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064990
Basic UDI-DI: 357302BUDI000236T9
Reference: 30413
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

Prolactin IRMA KIT

IM2121, IM3303

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590216733
Basic UDI-DI: 150995905PRLIRMAZK
Reference: IM2121
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

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THYMIDINE KINASE REA KIT

IM1948

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590216191
Basic UDI-DI: 150995905IM19486P
Reference: IM1948
EMDN: W0102039008
EMDN description: THYMIDINE KINASE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

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Immunoassay IM1441

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590214661
Basic UDI-DI: 150995905AFPIRMAN4
Reference: IM1441
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

IRMA α Subunit

IM1186

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213800
Basic UDI-DI: 150995905IM11865P
Reference: IM1186
EMDN: W0102039015
EMDN description: ALPHA SUBUNIT
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

β2-microglobulin RIA KIT

IM1113

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213633
Basic UDI-DI: 150995905IM11134U
Reference: IM1113
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

RIA DHEA Sulfate

IM0729

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590213107
Basic UDI-DI: 150995905IM072962
Reference: IM0729
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:43

Manufacturer products View details

DSL2700

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590211509
Basic UDI-DI: 150995905DSL2700F4
Reference: DSL2700
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:42

Manufacturer products View details

Inhibin B Gen II ELISA

A81303

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590206833
Basic UDI-DI: 150995905A81303SU
Reference: A81303
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:42

Manufacturer products View details

A15607

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590201708
Basic UDI-DI: 150995905A15607S2
Reference: A15607
EMDN: W0102039007
EMDN description: NEURON SPECIFIC ENOLASE
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:41

Manufacturer products View details

Access AFP (100 & 200 Test)(Reagent Pack)

33210

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231507
Basic UDI-DI: 150995901AccAFPLW
Reference: 33210
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Access AFP (300 & 600 Test Kit)

33211

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231491
Basic UDI-DI: 150995901AccAFP300PR
Reference: 33211
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:35

Manufacturer products Authorised representative products Authorised representative actors View details

Access AFP Sample Diluent

33216

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231477
Basic UDI-DI: 150995901AccAFPSamDilDU
Reference: 33216
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

ALI107G7

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627029423
Basic UDI-DI: B-00847627029423
Reference: ALI107G7
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

OPAI107T60

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Biocare Medical
Manufacturer SRN: US-MF-000034581
UDI-DI: 00847627025371
Basic UDI-DI: B-00847627025371
Reference: OPAI107T60
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Bulgaria
Authorised representative: Emergo Europe B.V.
Last updated: 30.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details