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132 device results listed.

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D-02B0017YS

Electrolyte（K∕ Na∕ Cl ∕Ca）Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0017YS
Basic UDI-DI: B-02B0017YS
Reference: 2Y001
EMDN: W01010304
EMDN description: CHLORIDE
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:29

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D-02B0016YQ

Urinary Microalbumin/Creatinine Reagent Kit (Fluorescence / Benedict-Behre method)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0016YQ
Basic UDI-DI: B-02B0016YQ
Reference: 1X001
EMDN: W01010207
EMDN description: CREATININE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:29

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D-02B0015YN

Glycated Hemoglobin Reagent Kit (Boric Acid Affinity Liquid Chromatography/Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0015YN
Basic UDI-DI: B-02B0015YN
Reference: 1P001
EMDN: W01010214
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:29

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D-02B0014YL

Total Bile Acid/Cholinesterase/α-Amylase Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0014YL
Basic UDI-DI: B-02B0014YL
Reference: 1Y001
EMDN: W01010202
EMDN description: BILE ACIDS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:29

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D-02B0013YJ

Direct Bilirubin/Total Protein/Alkaline Phosphatase/Glutamyl Transferase Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0013YJ
Basic UDI-DI: B-02B0013YJ
Reference: 1G001
EMDN: W0101060109
EMDN description: MULTIPLE PARAMETER BLOOD TEST
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:29

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D-02B0012YG

Blood Lipid Reagent Kit (TC/TG/HDL-C/LDL-C)

IVD generalIVDDOn the marketKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0012YG
Basic UDI-DI: B-02B0012YG
Reference: 1J001
EMDN: W01010205
EMDN description: CHOLESTEROL
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

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D-02B0011YE

Myocardial Enzyme Reagent Kit (CK, CK-MB, LDH, α -HBDH)

IVD generalIVDDOn the marketKitNear-patient testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0011YE
Basic UDI-DI: B-02B0011YE
Reference: 1T001
EMDN: W01010121
EMDN description: LACTATE DEHYDROGENASE ISOENZYMES
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

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D-02B0010YC

C-Reactive Protein/Serum Amyloid A Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0010YC
Basic UDI-DI: B-02B0010YC
Reference: 1Z001
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-02B0009YT

C-Reactive Protein Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0009YT
Basic UDI-DI: B-02B0009YT
Reference: 1E001
EMDN: W0102160601
EMDN description: C-REACTIVE PROTEIN - RT & POC
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

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D-02B0008YR

Glucose/Glycated Serum Albumin Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0008YR
Basic UDI-DI: B-02B0008YR
Reference: 1U001
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

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D-02B0006YM

Prothrombin Time Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0006YM
Basic UDI-DI: B-02B0006YM
Reference: 1S001
EMDN: W0103020801
EMDN description: PROTHROMBIN TIME RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-02B0007YP

APTT/PT/TT/FIB Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0007YP
Basic UDI-DI: B-02B0007YP
Reference: 1R001
EMDN: W0103020802
EMDN description: ACTIVATED PARTIAL THROMBOPLASTIN TIME - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-02B0005YK

Urea/Creatinine/Uric Acid Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0005YK
Basic UDI-DI: B-02B0005YK
Reference: 1N001
EMDN: W01010204
EMDN description: UREA/BLOOD UREA NITROGEN
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

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D-02B0004YH

Alanine Aminotransferase/Aspartate Aminotransferase/Total Bilirubin/Albumin Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0004YH
Basic UDI-DI: B-02B0004YH
Reference: 1F001
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-02B0003YF

β2-Microglobulin/Cystatin C Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0003YF
Basic UDI-DI: B-02B0003YF
Reference: 1O001
EMDN: W0102039002
EMDN description: BETA2-MICROGLOBULIN
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-02B0001YB

Glucose/Homocysteine/Uric Acid/Low Density Lipoprotein Cholesterol Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0001YB
Basic UDI-DI: B-02B0001YB
Reference: 1Q001
EMDN: W01010232
EMDN description: URIC ACID
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

D-01B0212YD

SPUG

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0212YD
Basic UDI-DI: B-01B0212YD
Reference: 4B003
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-01B0206YJ

Safe AQ UG

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0206YJ
Basic UDI-DI: B-01B0206YJ
Reference: 1V003
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-01B0112Y8

SPUG

IVD self-testing devicesIVDDOn the marketNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0112Y8
Basic UDI-DI: B-01B0112Y8
Reference: 4B002
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details

D-01B0111Y6

Safe AQ pro Ⅰ, Safe AQ pro Ⅱ, Safe AQ pro Ⅲ; Safe AQ maxⅠ, Safe AQ maxⅡ, Safe AQ max Ⅲ

IVD self-testing devicesIVDDOn the marketNear-patient testingReagentSelf testingSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-01B0111Y6
Basic UDI-DI: B-01B0111Y6
Reference: 5Y002, 5Z002, 6A002, 6B002, 6B003, 6C001, 6C002, 6C003, 6C004, 6C005, 6C006, 6C007, 6D004, 6D005, 6D006
EMDN: W0101060101
EMDN description: GLUCOSE TEST STRIPS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.07.2026 16:10

Manufacturer products Authorised representative products Authorised representative actors View details