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572 device results listed.

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Parathyroid Hormone CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590735
Basic UDI-DI: 697518250F117042K
Reference: F11704
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:30

Manufacturer products Authorised representative products Authorised representative actors View details

Total 25-hydroxy Vitamin D CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293590285
Basic UDI-DI: 697518250F124052D
Reference: F12405
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:28

Manufacturer products Authorised representative products Authorised representative actors View details

25-hydroxy vitamin D Determination Kit (Fluorescence Immunochromatographic Assay)

25 tests

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293580682
Basic UDI-DI: 697518250P113045Z
Reference: P11304
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details

25-hydroxy-vitamin D test (Up-converting Phosphor Technology)

IVD Class BNot specifiedOn the market

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700406689
Basic UDI-DI: 697029753307LF
Reference: HGUPT03
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 26.06.2026 14:20

Manufacturer products Authorised representative products Authorised representative actors View details

Bone Alkaline Phosphatase (BAP) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502484
Basic UDI-DI: B-06942028502484
Reference: DH0401
EMDN: W0102060318
EMDN description: BONE ALKALINE PHOSPHATASE (IC)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Total type I Collagen Amino Terminal Lengthening Peptide(P1NP) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502446
Basic UDI-DI: B-06942028502446
Reference: DH0301
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

Bone Gla Protein (BGP) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502408
Basic UDI-DI: B-06942028502408
Reference: DH0201
EMDN: W0102060311
EMDN description: OSTEOCALCINE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

β-Crosslaps(β-CTx) Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028502361
Basic UDI-DI: B-06942028502361
Reference: DH0101
EMDN: W0102060399
EMDN description: BONE METABOLISM TESTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details

06941967225041

IVD generalNot specifiedOn the market

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967225041
Basic UDI-DI: B-06941967225041
Reference: 01.09.4F. 01.01.02
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 25.06.2026 20:48

Manufacturer products Authorised representative products Authorised representative actors View details

25-Hydroxyvitamin D Kit (Fluorescence Immunochromatography)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06941377306453
Basic UDI-DI: B-06941377306453
Reference: PO-0009-01
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 25.06.2026 07:18

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ TOTAL 25OH VITAMIN D

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405349
Basic UDI-DI: 69713904311067S
Reference: 011106601
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:07

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PTH

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405325
Basic UDI-DI: 693971641102L7
Reference: 011102601
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:07

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ PTH

IVD Class BNot specifiedOn the marketDirect marking

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405318
Basic UDI-DI: 693971641102L7
Reference: 011102001
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 25.06.2026 02:07

Manufacturer products Authorised representative products Authorised representative actors View details

06937287300650

IVD generalNot specifiedOn the market

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
Manufacturer SRN: CN-MF-000043067
UDI-DI: 06937287300650
Basic UDI-DI: B-06937287300650
Reference: 100 tests/kit
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 24.06.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

Total Procollagen I N-Terminal Propeptide Kit (CLIA)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751673
Basic UDI-DI: B-06936595751673
Reference: FG1454Y
EMDN: W0102060317
EMDN description: PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

25-Hydroxy Vitamin D Total Kit (CLIA)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751642
Basic UDI-DI: B-06936595751642
Reference: FG1451Y
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

Intact Parathyroid Hormone Kit (CLIA)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595751635
Basic UDI-DI: B-06936595751635
Reference: FG1450Y
EMDN: W0102060312
EMDN description: PARATHYROID HORMONE INTACT
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

25-Hydroxy Vitamin D Kit (Latex-Enhanced Immunoturbidimetric Method)

IVD generalNot specifiedOn the market

Manufacturer: MedicalSystem Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000010246
UDI-DI: 06936595750775
Basic UDI-DI: B-06936595750775
Reference: MJ454Y
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 18:55

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: 06925912718543
Basic UDI-DI: 692591270020GP
Reference: C86023
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 14:12

Manufacturer products Authorised representative products Authorised representative actors View details

Finecare

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289836562
Basic UDI-DI: B-06933289836562
Reference: W241P0008
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 24.06.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details