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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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IRMA MUC-1 gene associated antigen (CA 15-3)

IM2397, B64314

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590217402
Basic UDI-DI: 150995905CA15-3IRMAMG
Reference: IM2397
EMDN: W0102030102
EMDN description: CANCER ANTIGEN 15-3
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

Manufacturer products View details

IRMA CA 125 antigen

IM2233, B64312

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590217020
Basic UDI-DI: 150995905CA125IRMAFQ
Reference: IM2233
EMDN: W0102030106
EMDN description: CANCER ANTIGEN 125
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

Manufacturer products View details

IM2204

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590216887
Basic UDI-DI: 150995905CEAIRMAHL
Reference: IM2204
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

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

Manufacturer products View details

PSA total IRMA KIT

Immunoassay IM1950

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590216207
Basic UDI-DI: 150995905IM19506A
Reference: IM1950
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:44

Manufacturer products View details

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

Manufacturer products View details

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

Cytokeratin 19 Fragment IRMA Kit

A56888

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590205355
Basic UDI-DI: 150995905A56888UR
Reference: A56888
EMDN: W0102030126
EMDN description: CYTOKERATINS
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 Hybritech PSA (Sample Diluent)

37206

IVD Class CIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232351
Basic UDI-DI: 150995901AccHPSASamDilY7
Reference: 37206
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
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 Hybritech free PSA (Reagent Pack)

37210

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232344
Basic UDI-DI: 150995901AccHfPSAMQ
Reference: 37210
EMDN: W0102030114
EMDN description: FREE PROSTATIC SPECIFIC ANTIGEN
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 (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

Access Hybritech PSA (Reagent Pack)

37200

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590224592
Basic UDI-DI: 150995901AccHPSA2E
Reference: 37200
EMDN: W0102030113
EMDN description: TOTAL PROSTATIC SPECIFIC ANTIGEN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:33

Manufacturer products Authorised representative products Authorised representative actors View details