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44 device results listed.

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IDS-iSYS N-MID® Osteocalcin

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690226
Basic UDI-DI: B-05060169690226
Reference: IS-2900
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.08.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

04560189213258

AIA-PACK Osteocalcin CONTROL SET

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213258
Basic UDI-DI: B-04560189213258
Reference: 0025436
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

04560189213241

ST AIA-PACK Osteocalcin SAMPLE DILUTING SOLUTION

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04560189213241
Basic UDI-DI: B-04560189213241
Reference: 0025536
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 02.08.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

N-MID Osteocalcin (eCLIA)

50T，2×50T，100T，2×100T

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063935
Basic UDI-DI: 69703416803205102J4
Reference: 0320510501
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

Osteocalcin CLIA Microparticles

AutoLumo analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359542265
Basic UDI-DI: 697015090000045H6
Reference: CMS0103
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Osteocalcin

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

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912720461
Basic UDI-DI: 692591270277HW
Reference: C86289
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:36

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

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

Osteocalcin Assay Kit (ECLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Jiangsu Sunlant Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000025940
UDI-DI: D-SEK015DK
Basic UDI-DI: B-SEK015DK
Reference: SE-K015
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 06:12

Manufacturer products Authorised representative products Authorised representative actors View details

Osteocalcin Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD195Y3
Basic UDI-DI: B-GKPD195Y3
Reference: GKPD195
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:40

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

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

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

14560189213217

ST AIA-PACK Osteocalcin

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 14560189213217
Basic UDI-DI: B-14560189213217
Reference: 0025236
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

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: 10850076346420
Basic UDI-DI: B-10850076346420
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 04:40

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

Osteocalcin CLIA Microparticles

IVD Class BNot specifiedOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359542289
Basic UDI-DI: 697015090000045H6
Reference: CMS0105
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 08.07.2026 19:47

Manufacturer products Authorised representative products Authorised representative actors View details

06979878281191

N-MID Osteocalcin Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281191
Basic UDI-DI: B-06979878281191
Reference: 1001017
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:50

Manufacturer products Authorised representative products Authorised representative actors View details

Osteocalcin Assay Reagent Kit (CMIA)

C2KA003

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753477342
Basic UDI-DI: B-06976753477342
Reference: C2KA003
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:01

Manufacturer products Authorised representative products Authorised representative actors View details