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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

ADVIA Centaur Progesterone

IVDR_67_TTN_DUB-C_B_KIT_Progesterone

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414204147
Basic UDI-DI: 0405686901624VN
Reference: 10310305
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Prolactin

IVDR_67_TTN_DUB-C_B_KIT_PRL

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177267
Basic UDI-DI: 0405686901623VL
Reference: 10309975
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® FSH

IVDR_67_TTN_DUB-C_B_KIT_FSH

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177243
Basic UDI-DI: 0405686901612VF
Reference: 10309973
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® LH

IVDR_67_TTN_DUB-C_B_KIT_LH

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414177229
Basic UDI-DI: 0405686901617VR
Reference: 10309971
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 00:22

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Osteocalcin

IVDR_67_LLB_DUB-C_B_KIT_Osteocalcin

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414961781
Basic UDI-DI: 0405686900227UZ
Reference: 10381477
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-Z130014H

N/A

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z130014H
Basic UDI-DI: B-Z130014H
Reference: Z13001
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 14:12

Manufacturer products View details

Bio·Firm

WO-VD-C41-25

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Wantaifu Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000037582
UDI-DI: D-WO-VD-C41-2565
Basic UDI-DI: B-WO-VD-C41-2565
Reference: WO-VD-C41-25
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 13:32

Manufacturer products Authorised representative products Authorised representative actors View details

INS Insulin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-W0102060103CB
Basic UDI-DI: B-W0102060103CB
Reference: INS706-AE10Y, INS706-AE10N, INS706-AE20Y, INS706-AE20N
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 13:28

Manufacturer products Authorised representative products Authorised representative actors View details

B-type Brain Natriuretic Peptide Test Kit

VID81-

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID81-FD
Basic UDI-DI: B-VID81-FD
Reference: VID81- 01-011
EMDN: W0102060499
EMDN description: ENDOCRINE HORMONES (GROWTH FACTORS) - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

Parathyroid Hormone Test Kit

VID74-

IVD generalIVDDOn the marketAnimal tissuesInstrumentKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID74-FH
Basic UDI-DI: B-VID74-FH
Reference: VID74- 05-011
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

Human Growth Hormone Test Kit

VID73-

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID73-FE
Basic UDI-DI: B-VID73-FE
Reference: VID73- 05-011
EMDN: W0102060402
EMDN description: HUMAN GROWTH HORMONE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details