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EUDAMED Device Search

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IRMA PTH

Immunoassay, A11930, B89461

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: IMMUNOTECH s.r.o.
Manufacturer SRN: CZ-MF-000001761
UDI-DI: 15099590201517
Basic UDI-DI: 150995905PTHIRMAYZ
Reference: A11930, B89461
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Czechia
Authorised representative: -
Last updated: 30.07.2026 20:41

Manufacturer products View details

Access Ostase Reagent Pack

37300

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590232313
Basic UDI-DI: 150995901AccOstUS
Reference: 37300
EMDN: W0102060318
EMDN description: BONE ALKALINE PHOSPHATASE (IC)
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 Ultrasensitive hGH Reagent Pack

33580

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231132
Basic UDI-DI: 150995901AcchGHRT
Reference: 33580
EMDN: W0102060402
EMDN description: HUMAN GROWTH HORMONE
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 Cortisol (Reagent Pack)

33600

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231118
Basic UDI-DI: 150995901AccCortAP
Reference: 33600
EMDN: W0102060203
EMDN description: CORTISOL
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 Ultrasensitive Insulin (Reagent Pack)

33410

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590230623
Basic UDI-DI: 150995901AccuInsEX
Reference: 33410
EMDN: W0102060103
EMDN description: INSULIN
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 25(OH) Vitamin D Total Reagent Pack

A98856

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226558
Basic UDI-DI: 150995901AccVitDDxRV
Reference: A98856
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
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 25(OH) Vitamin D Total Reagent Pack

B24838

IVD Class BIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590225964
Basic UDI-DI: 150995901AccVitDA2ML
Reference: B24838
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
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 Intact PTH Reagent Pack

A16972

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590201937
Basic UDI-DI: 150995901AccInPTHQC
Reference: A16972
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:32

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-hGH

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76029FK
Basic UDI-DI: B-DC76029FK
Reference: DC76029
EMDN: W0102060402
EMDN description: HUMAN GROWTH HORMONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Gastrin-17

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76027FF
Basic UDI-DI: B-DC76027FF
Reference: DC76027
EMDN: W0102069001
EMDN description: GASTRIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.07.2026 18:08

Manufacturer products Authorised representative products Authorised representative actors View details

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