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172 device results listed.

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tPSA Control

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762858
Basic UDI-DI: 697134876246C28584L
Reference: MF-246
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Total Thyroxine (TT4) Diagnostic Kit ( Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762803
Basic UDI-DI: 697134876022B2803XH
Reference: MF-022-20
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Total Triiodothyronine (TT3) Diagnostic Kit ( Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762797
Basic UDI-DI: 697134876023B2797YU
Reference: MF-021-20
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid-Stimulating Hormone（TSH）Diagnostic Kit (Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762780
Basic UDI-DI: 697134876020B2780X4
Reference: MF-020-20
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Total Prostate Specific Antigen (tPSA) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762773
Basic UDI-DI: 697134876046C277335
Reference: MF-046-20
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Prolactin (PRL) Diagnostic Kit (Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762766
Basic UDI-DI: 697134876017B2766ZL
Reference: MF-017-20
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin (PCT) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762759
Basic UDI-DI: 697134876027C27592N
Reference: MF-027-20
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone (LH) Diagnostic Kit ( Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762742
Basic UDI-DI: 697134876015B2742YC
Reference: MF-015-20
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Glycosylated Hemoglobin (HbA1c) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762735
Basic UDI-DI: 697134876037C27352R
Reference: MF-037-20
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Free Thyroxine（FT4） Diagnostic Kit ( Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762728
Basic UDI-DI: 697134876024B2728YN
Reference: MF-024-20
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Free Triiodothyronine（FT3） Diagnostic Kit ( Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762711
Basic UDI-DI: 697134876023B2711XQ
Reference: MF-023-20
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Follicle Stimulating Hormone（FSH）Diagnostic Kit ( Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762704
Basic UDI-DI: 697134876016B2704YH
Reference: MF-016-20
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Free Prostate Specific Antigen (fPSA) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762698
Basic UDI-DI: 697134876047C26983V
Reference: MF-047-20
EMDN: W0102039099
EMDN description: TUMOUR MARKERS - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin (FERR) Diagnostic Kit (Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762681
Basic UDI-DI: 697134876012B2681XA
Reference: MF-012-20
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762667
Basic UDI-DI: 697134876034B2667ZC
Reference: MF-034-20
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein (CRP) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762650
Basic UDI-DI: 697134876028C26502C
Reference: MF-028-20
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

25-Hydroxyvitamin D (25-OH VD) Diagnostic Kit ( Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762643
Basic UDI-DI: 697134876042B2643YM
Reference: MF-042-20
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:50

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin (FERR) Diagnostic Kit (Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764562
Basic UDI-DI: 697134876012B2681XA
Reference: MF-012-25
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone (LH) Diagnostic Kit ( Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764579
Basic UDI-DI: 697134876015B2742YC
Reference: MF-015-25
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Follicle Stimulating Hormone（FSH）Diagnostic Kit ( Immunochromatographic Assay)

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764586
Basic UDI-DI: 697134876016B2704YH
Reference: MF-016-25
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 26.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details