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Procalcitonin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 10850076346109
Basic UDI-DI: B-10850076346109
Reference: CDPCT-401a
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 04:36

Manufacturer products Authorised representative products Authorised representative actors View details

ClinRep®

1000

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: RECIPE Chemicals + Instruments GmbH
Manufacturer SRN: DE-MF-000032553
UDI-DI: D-1000BAMICC
Basic UDI-DI: B-1000BAMICC
Reference: 1000
EMDN: W0102060601
EMDN description: ADRENALIN / NORADRENALINE / DOPAMINE
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 00:35

Manufacturer products View details

Renin (eCLIA)

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984067155
Basic UDI-DI: 69703416803205109JJ
Reference: 0320511901
EMDN: W0102060204
EMDN description: RENINE (PLASMA RENINE ACTIVITY)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details

Renin (eCLIA)

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984067179
Basic UDI-DI: 69703416803205109JJ
Reference: 0320511902
EMDN: W0102060204
EMDN description: RENINE (PLASMA RENINE ACTIVITY)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

Renin (eCLIA)

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984067162
Basic UDI-DI: 69703416803205109JJ
Reference: 0320511904
EMDN: W0102060204
EMDN description: RENINE (PLASMA RENINE ACTIVITY)
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

IGFBP-3 (eCLIA)

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064079
Basic UDI-DI: 69703416803205106JC
Reference: 0320509503
EMDN: W0102060406
EMDN description: INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

FREND Vitamin D

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540337
Basic UDI-DI: B-08809317540337
Reference: FRVDAP 020
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:42

Manufacturer products Authorised representative products Authorised representative actors View details

FREND Vitamin D

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540115
Basic UDI-DI: B-08809317540115
Reference: FRVD 020
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Cyprus
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

FREND PCT

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: NanoEntek, Inc.
Manufacturer SRN: KR-MF-000021903
UDI-DI: 08809317540054
Basic UDI-DI: B-08809317540054
Reference: FRPC 025
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Cyprus
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 13:41

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur Testosterone II

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414591148
Basic UDI-DI: 0405686901634VR
Reference: 10696863
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Testosterone II (TSTII)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600215
Basic UDI-DI: 0405686901634VR
Reference: 10995707
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Testosterone II (TSTII)

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414600222
Basic UDI-DI: 0405686901634VR
Reference: 10995708
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 10.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI 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: 06947145580636
Basic UDI-DI: 694714551037J3
Reference: 1302563005M
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Angiotensin I (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145580643
Basic UDI-DI: 694714551037J3
Reference: 1602011037MT
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.07.2026 06:44

Manufacturer products Authorised representative products Authorised representative actors View details

N-MID Osteocalcin (eCLIA)

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063959
Basic UDI-DI: 69703416803205102J4
Reference: 0320510503
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 23:01

Manufacturer products Authorised representative products Authorised representative actors View details

hGH (eCLIA)

IVD Class BNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984064116
Basic UDI-DI: 69703416803205097K4
Reference: 0320509603
EMDN: W0102060402
EMDN description: HUMAN GROWTH HORMONE
First on market country: Netherlands
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 09.07.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

Cortisol & Cortisone Reagent Set

IVD Annex II List BIVDDOn the marketKitProfessional testingReagent

Manufacturer: Diagnotix B.V.
Manufacturer SRN: NL-MF-000000236
UDI-DI: 08720514311714
Basic UDI-DI: B-08720514311714
Reference: 1040 M CORT
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Netherlands
Authorised representative: -
Last updated: 09.07.2026 19:16

Manufacturer products View details

RapidFor™ Vitamin D Rapid Test Kit (FIA)

VMPO89

IVD generalIVDDOn the marketInstrumentKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595039304
Basic UDI-DI: B-08684595039304
Reference: VMPO89FC
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:17

Manufacturer products View details

RapidFor™ PCT Rapid Test Kit

VMD47

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030837
Basic UDI-DI: B-08684595030837
Reference: VMD47
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:14

Manufacturer products View details

RapidFor™ Vitamin-D Rapid Test Kit

VMD64

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030820
Basic UDI-DI: B-08684595030820
Reference: VMD64
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:14

Manufacturer products View details