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08800111724046

i-INS-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111724046
Basic UDI-DI: 88001117IPBA01IA38WG
Reference: 16INS10D
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ i Cortisol

i-CTS-01

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111723483
Basic UDI-DI: 88001117IPCA01IA36WX
Reference: 16COR10D
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Austria
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:41

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® FGF 23

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771102728
Basic UDI-DI: 80567713187005R
Reference: 318700
EMDN: W0102060499
EMDN description: ENDOCRINE HORMONES (GROWTH FACTORS) - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:08

Manufacturer products View details

25-OH Vitamin D Total II (Electrochemiluminescence Immunoassay)

50T，2×50T，100T，2×100T

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984067094
Basic UDI-DI: 69703416803205150JF
Reference: 693111
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

PCT STAT (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062983
Basic UDI-DI: 69703416803205093JU
Reference: 0320510401
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

Cortisol (eCLIA)

50T, 2×50T, 100T, 2×100T

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062884
Basic UDI-DI: 69703416803205105JA
Reference: 0320510303
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 11:03

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Angiotensin I (CLIA)

Angiotensin I (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145580629
Basic UDI-DI: 694714551037J3
Reference: 1306563005M
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST B·R·A·H·M·S PCT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595301155
Basic UDI-DI: 4987595PF1221KXD
Reference: 30115
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7022 · Rev. 5
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:40

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Atellica IM Follicle Stimulating Hormone (FSH)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599052
Basic UDI-DI: 0405686901612VF
Reference: 10995581
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

MassTrak™

Masstrak™ Vitamin D Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Waters Corporation
Manufacturer SRN: US-MF-000025801
UDI-DI: 00816776020377
Basic UDI-DI: 081677602VTDKIT0608D9
Reference: 186008096IVD
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 04:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Testosterone II

IVDR_67_TTN_DUB-C_B_KIT_TSTII

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414591131
Basic UDI-DI: 0405686901634VR
Reference: 10696862
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur BRAHMS Procalcitonin

IVDR_67_TTN_DUB-C_C_KIT_PCT

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414246536
Basic UDI-DI: 0405686901818W5
Reference: 11202697
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:33

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension EXL LOCI Vitamin D Total Assay Flex reagent cartridge

IVDR_67_GLA_DUB-C_B_REAG_VITD

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768037740
Basic UDI-DI: 0405686901223UY
Reference: 10706480
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 ECP

IVDR_67_LLB_DUB-C_B_KIT_ECP

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414966076
Basic UDI-DI: 0405686901378VW
Reference: 10380874
EMDN: W0102060699
EMDN description: MULTIPLE INDIVIDUAL HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:26

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Pyrilinks-D

IVDR_67_LLB_DUB-C_B_KIT_Pyrilinks-D

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961859
Basic UDI-DI: 0405686901403V4
Reference: 10381461
EMDN: W0102060307
EMDN description: DEOXYPYRIDINOLINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Growth Hormone (hGH)

IVDR_67_LLB_DUB-C_B_REAG_KIT_hGH

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961552
Basic UDI-DI: 0405686901387VX
Reference: 10381451
EMDN: W0102060402
EMDN description: HUMAN GROWTH HORMONE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Calcitonin

IVDR_67_LLB_DUB-C_C_KIT_Calcitonin

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961156
Basic UDI-DI: 0405686901442VE
Reference: 10381446
EMDN: W0102060301
EMDN description: CALCITONIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:25

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Sex Hormone Binding Globulin (SHBG)

IVDR_67_TTN_DUB-C_B_KIT_SHBG

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414599854
Basic UDI-DI: 0405686901626VS
Reference: 10995672
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Cortisol (Cor)

IVDR_67_TTN_DUB-C_B_KIT_Cor

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414598659
Basic UDI-DI: 0405686901606VL
Reference: 10995538
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® PTH

IVDR_67_TTN_DUB-C_B_KIT_PTH

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414592336
Basic UDI-DI: 0405686901625VQ
Reference: 10699154
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:23

Manufacturer products Authorised representative products Authorised representative actors View details