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iFlash-PCT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912715306
Basic UDI-DI: 692591270050GY
Reference: C86039-L
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:29

Manufacturer products Authorised representative products Authorised representative actors View details

ATK Vit D

25-OH Vitamin D ELISA kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Arghavan Teb Kavian
Manufacturer SRN: IR-MF-000045430
UDI-DI: 06260001187139
Basic UDI-DI: 62600011ATK.VITDAB
Reference: ATK.E071
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Spain
Authorised representative: Medisol Technologies S.L.
Last updated: 31.07.2026 17:31

Manufacturer products Authorised representative products Authorised representative actors View details

IDK® Steroid Panel Basic LC-MS/MS

Pregnenolonsulfat LC-MS/MS Kit

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598015494
Basic UDI-DI: B-04050598015494
Reference: KM2100
EMDN: W0102060203
EMDN description: CORTISOL
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

total sRANKL ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598110168
Basic UDI-DI: B-04050598110168
Reference: K 1016
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

1,25-(OH)2-Vitamin D ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598121126
Basic UDI-DI: B-04050598121126
Reference: K 2112
EMDN: W0102060308
EMDN description: 1.25-DIHYDROXYVITAMIN D
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

VDBP ELISA

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598123144
Basic UDI-DI: B-04050598123144
Reference: K 2314
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

Adiponectin (total) ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598162501
Basic UDI-DI: B-04050598162501
Reference: K 6250
EMDN: W0102069099
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

Manufacturer products View details

IDS ACTH II

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169696457
Basic UDI-DI: 5060169696457YN
Reference: IS-4500NG
EMDN: W0102060401
EMDN description: ADRENOCORTIOTROPIC HORMONE
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

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

IDS-iSYS 25 VitDS

IS-2500N

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169695283
Basic UDI-DI: 5060169695283Y6
Reference: IS-2500N
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
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

IDS Cortisol

IS-4600

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690691
Basic UDI-DI: 5060169690691XN
Reference: IS-4600
EMDN: W0102060203
EMDN description: CORTISOL
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

N-MID® Osteocalcin ELISA

N-MID Osteocalcin ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690516
Basic UDI-DI: 5060169690516X3
Reference: AC-11F12
EMDN: W0102060311
EMDN description: OSTEOCALCINE
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

25-Hydroxy Vitamin DS EIA

AC-57SF1

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690455
Basic UDI-DI: 5060169690455X8
Reference: AC-57SF1
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
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 CartiLaps® (CTX-II) EIA

AC-10F1

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690172
Basic UDI-DI: 5060169690172WR
Reference: AC-10F1
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
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

Alpha CrossLaps® (CTX-I) ELISA

AC-04F1

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690165
Basic UDI-DI: 5060169690165WU
Reference: AC-04F1
EMDN: W0102060317
EMDN description: PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE
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

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

1,25-Dihydroxy Vitamin D EIA

AC-62F1

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690097
Basic UDI-DI: 5060169690097X4
Reference: AC-62F1
EMDN: W0102060308
EMDN description: 1.25-DIHYDROXYVITAMIN D
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

Ostase® BAP EIA

AC-20F1

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

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690059
Basic UDI-DI: 5060169690059WU
Reference: AC-20F1
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
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