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D-3025A4

25-OH-Vitamin D in vitro diagnostic kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Aikang Diagnostics Co., Ltd
Manufacturer SRN: CN-MF-000028962
UDI-DI: D-3025A4
Basic UDI-DI: B-3025A4
Reference: AKBR3025030
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Spain
Authorised representative: MedNet EC-REP GmbH
Last updated: 11.07.2026 18:07

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH Vitamin D Total (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-25-OHVD706-AESU
Basic UDI-DI: B-25-OHVD706-AESU
Reference: 25-OHVD706-AE10Y, 25-OHVD706-AE10N, 25-OHVD706-AE20Y, 25-OHVD706-AE20N
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 11.07.2026 15:47

Manufacturer products Authorised representative products Authorised representative actors View details

Parathyroid Hormone Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346434
Basic UDI-DI: B-20850076346434
Reference: CIPTH-301a
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

N-MID Osteocalcin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346427
Basic UDI-DI: B-20850076346427
Reference: CIMID(N)-301a
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

25-OH-Vitamin D Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: 20850076346410
Basic UDI-DI: B-20850076346410
Reference: CIVD-301a
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 15:03

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Osteocalcin

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720478
Basic UDI-DI: 692591270277HW
Reference: C86289-S
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Calcitonin

IVD Class CNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720508
Basic UDI-DI: 692591270275HS
Reference: C86291-S
EMDN: W0102060301
EMDN description: CALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-25-OH Vitamin D

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723110
Basic UDI-DI: 692591270020GP
Reference: C86319
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-PTH

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723158
Basic UDI-DI: 692591270021GR
Reference: C86038-S
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-25-OH Vitamin D Ⅱ

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912724308
Basic UDI-DI: 692591270278HY
Reference: C86326-S
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-25-OH Vitamin D Ⅱ

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912734482
Basic UDI-DI: 692591270278HY
Reference: C86326-L
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:38

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

25-OH-VD Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763532
Basic UDI-DI: B-15065023763532
Reference: TV20015
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Romania
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:35

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

25-hydroxy vitamin D Rapid Test (LFA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763327
Basic UDI-DI: B-15065023763327
Reference: TV10033
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

14562185400929

CL AIA-PACK Intact PTH ADJUSTER SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14562185400929
Basic UDI-DI: B-14562185400929
Reference: 0029240
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

14562185400912

CL AIA-PACK Intact PTH TEST CUP

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14562185400912
Basic UDI-DI: B-14562185400912
Reference: 0029140
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

14560189215679

CL AIA-PACK Osteocalcin ADJUSTER SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189215679
Basic UDI-DI: B-14560189215679
Reference: 0029254
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:03

Manufacturer products Authorised representative products Authorised representative actors View details

14560189215594

CL AIA-PACK Osteocalcin TEST CUP

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189215594
Basic UDI-DI: B-14560189215594
Reference: 0029154
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:02

Manufacturer products Authorised representative products Authorised representative actors View details

14560189215006

CL AIA-PACK 25-OH Vitamin D PRETREATMENT CUP

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189215006
Basic UDI-DI: B-14560189215006
Reference: 0029546
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:02

Manufacturer products Authorised representative products Authorised representative actors View details

14560189214993

CL AIA-PACK 25-OH Vitamin D ADJUSTER SET

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189214993
Basic UDI-DI: B-14560189214993
Reference: 0029246
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:02

Manufacturer products Authorised representative products Authorised representative actors View details

14560189214986

CL AIA-PACK 25-OH Vitamin D TEST CUP

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189214986
Basic UDI-DI: B-14560189214986
Reference: 0029146
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 11.07.2026 08:02

Manufacturer products Authorised representative products Authorised representative actors View details