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EUDAMED Device Search

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02.08.2026 18:51

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10 device results listed.

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IDS-iSYS CTX-I (CrossLaps®)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690240
Basic UDI-DI: B-05060169690240
Reference: IS-3000
EMDN: W0102060304
EMDN description: CROSS-LINKED C-TELOPEPTIDES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

IDS Beta CrossLaps® (CTX-I)

IS-3000N

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169695986
Basic UDI-DI: 5060169695986ZF
Reference: IS-3000N
EMDN: W0102060304
EMDN description: CROSS-LINKED C-TELOPEPTIDES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:33

Manufacturer products Authorised representative products Authorised representative actors View details

Serum CrossLaps® (CTX-I) ELISA

AC-02F1

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690134
Basic UDI-DI: 5060169690134WH
Reference: AC-02F1
EMDN: W0102060304
EMDN description: CROSS-LINKED C-TELOPEPTIDES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

Urine BETA CrossLaps® (CTX-I) ELISA

AC-05F1

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690158
Basic UDI-DI: 5060169690158WX
Reference: AC-05F1
EMDN: W0102060304
EMDN description: CROSS-LINKED C-TELOPEPTIDES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

Urine CrossLaps® (CTX-I) EIA

AC-03F1

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690141
Basic UDI-DI: 5060169690141WE
Reference: AC-03F1
EMDN: W0102060304
EMDN description: CROSS-LINKED C-TELOPEPTIDES
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 31.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors View details

β-cTx Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK016DM
Basic UDI-DI: B-SEK016DM
Reference: SE-K016
EMDN: W0102060304
EMDN description: CROSS-LINKED C-TELOPEPTIDES
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

LH Test (FIA)

25 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139075845
Basic UDI-DI: B-06978139075845
Reference: 0320302702
EMDN: W0102060304
EMDN description: CROSS-LINKED C-TELOPEPTIDES
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 01:40

Manufacturer products Authorised representative products Authorised representative actors View details

LH Test (FIA)

25 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06978139071304
Basic UDI-DI: B-06978139071304
Reference: 0320302702
EMDN: W0102060304
EMDN description: CROSS-LINKED C-TELOPEPTIDES
First on market country: Netherlands
Authorised representative: Umedwings Netherlands B.V.
Last updated: 07.07.2026 01:39

Manufacturer products Authorised representative products Authorised representative actors View details

IDS Beta CrossLaps® (CTX-I) Calibrator Set

IVD Class BNot specifiedOn the market

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169696013
Basic UDI-DI: 5060169695986ZF
Reference: IS-3020N
EMDN: W0102060304
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 21.06.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details

IDS Beta CrossLaps® (CTX-I) Control Set

IVD Class BNot specifiedOn the market

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169696051
Basic UDI-DI: 5060169695986ZF
Reference: IS-3030N
EMDN: W0102060304
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 21.06.2026 13:44

Manufacturer products Authorised representative products Authorised representative actors View details