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Sample Diluent 3

1×25mL,1×50 mL,2×25mL,2×50mL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06980120080158
Basic UDI-DI: 69703416803205170JM
Reference: 0320518701
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Sample Diluent 2

1×25mL,1×50 mL,2×25mL,2×50mL

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06980120080110
Basic UDI-DI: 69703416803205169K4
Reference: 0320518605
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.09.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Fastep Male Fertility (SP-10) Home Test

Device

IVD Class BIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804830809
Basic UDI-DI: 69528048A06610H2B
Reference: A06610H21
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 22:36

Manufacturer products Authorised representative products Authorised representative actors View details

Ferritin Fast Test Kit (Immunofluorescence Assay)

Ferritin Fast Test Kit (Immunofluorescence Assay)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414792898
Basic UDI-DI: 695441470265HJ
Reference: IF5077
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 23.09.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Spinreact S.A.U.
Manufacturer SRN: ES-MF-000011023
UDI-DI: 08431673171025
Basic UDI-DI: 8431673TLTF402R
Reference: 1107101L
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: -
Last updated: 23.09.2026 21:37

Manufacturer products View details

Serum Amyloid A Protein Reagent (Immunonephelometric Method)

-

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098959
Basic UDI-DI: B-06970493098959
Reference: XQ-0010-02
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent (Immunonephelometric Method)

-

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098966
Basic UDI-DI: B-06970493098966
Reference: XQ-0010-03
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent (Immunonephelometric Method)

-

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098973
Basic UDI-DI: B-06970493098973
Reference: XQ-0010-04
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent (Immunonephelometric Method)

-

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098980
Basic UDI-DI: B-06970493098980
Reference: XQ-0010-05
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent (Immunonephelometric Method)

-

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098997
Basic UDI-DI: B-06970493098997
Reference: XQ-0010-06
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent (Immunonephelometric Method)

-

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493099000
Basic UDI-DI: B-06970493099000
Reference: XQ-0010-07
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent (Immunonephelometric Method)

-

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493099017
Basic UDI-DI: B-06970493099017
Reference: XQ-0010-08
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent (Immunonephelometric Method)

-

IVD generalNot specifiedOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493099024
Basic UDI-DI: B-06970493099024
Reference: XQ-0010-09
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein Control

1×1.0mL（Control 1）

IVD Class CIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493097150
Basic UDI-DI: 6970493090506002NT
Reference: MY-0003-01
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 23.09.2026 21:21

Manufacturer products Authorised representative products Authorised representative actors View details

TRAb

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

Manufacturer: Abbott Ireland, Diagnostics Division
Manufacturer SRN: IE-MF-000009849
UDI-DI: 00380740179410
Basic UDI-DI: 038074ARP0908Q7
Reference: 09P0825
EMDN: W0102100304
EMDN description: THYROID STIMULATING IMMUNOGLOBULIN
First on market country: Ireland
Authorised representative: -
Last updated: 23.09.2026 19:42

Manufacturer products View details

LH Ovulation Test (Colloidal Gold)

Cassette Strip Midstream

IVD Class BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062770572
Basic UDI-DI: 69520627J002KY
Reference: LH1UST-1
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 23.09.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Test (Colloidal Gold)

Cassette Strip Midstream

IVD Class BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062770589
Basic UDI-DI: 69520627J002KY
Reference: LH1UST-2
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 23.09.2026 19:35

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Test (Colloidal Gold)

LH Ovulation Test (Colloidal Gold)

IVD Class BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062779322
Basic UDI-DI: 69520627J002KY
Reference: LH1UST-3
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 23.09.2026 19:35

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Test (Colloidal Gold)

Cassette Strip Midstream

IVD Class BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062770596
Basic UDI-DI: 69520627J002KY
Reference: LH1UST-5
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 23.09.2026 19:35

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Test (Colloidal Gold)

Cassette Strip Midstream

IVD Class BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062779346
Basic UDI-DI: 69520627J002KY
Reference: LH1UST- 10
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 23.09.2026 19:35

Manufacturer products Authorised representative products Authorised representative actors View details