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FE Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202209635
Basic UDI-DI: 69422022W0101909903R0VL
Reference: 3022960
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:11

Manufacturer products Authorised representative products Authorised representative actors View details

FE Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202209642
Basic UDI-DI: 69422022W0101909903R0VL
Reference: 3022990
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: -
Authorised representative: Emergo Europe B.V.
Last updated: 21.09.2026 17:11

Manufacturer products Authorised representative products Authorised representative actors View details

Phosphorus UV (Single Reagent)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Spectrum for Diagnostic Industries (Joint Stock Company)
Manufacturer SRN: EG-MF-000033954
UDI-DI: G458294001VN
Basic UDI-DI: B-G458294001VN
Reference: 294 001
EMDN: W01010307
EMDN description: PHOSPHATE INORGANIC / PHOSPHORUS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 19.08.2026 14:01

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control Material

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984062044
Basic UDI-DI: 6970341680320200101JD
Reference: 0320200301
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.08.2026 22:00

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginal pH Control

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrVPHLC69
Basic UDI-DI: B-acrVPHLC69
Reference: acrVPHLC
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Transferrin Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrTF602V4
Basic UDI-DI: B-acrTF602V4
Reference: acrTF602
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

G6PD Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrG6PD402XJ
Basic UDI-DI: B-acrG6PD402XJ
Reference: acrG6PD402
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

FOB/Transferrin/Calprotectin/Lactoferrin Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrFIB647SS
Basic UDI-DI: B-acrFIB647SS
Reference: acrFIB647
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Triglycerides Test Strip

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acr004HRC
Basic UDI-DI: B-acr004HRC
Reference: acr004H
EMDN: W0101060105
EMDN description: TRIGLYCERIDE TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

High-density Lipoprotein Test Strip

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acr003HR9
Basic UDI-DI: B-acr003HR9
Reference: acr003H
EMDN: W0101060103
EMDN description: HDL TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Total Cholesterol Test Strip

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acr002HR6
Basic UDI-DI: B-acr002HR6
Reference: acr002H
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

IDK® Vitamin K1/K2 HPLC

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598017191
Basic UDI-DI: B-04050598017191
Reference: KC2452
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 12.08.2026 23:38

Manufacturer products View details

Vitamin B12 Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrVB12402F3Q
Basic UDI-DI: B-acrVB12402F3Q
Reference: acrVB12402F
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

Triglycerides Test Strips

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrTG411BUH
Basic UDI-DI: B-acrTG411BUH
Reference: acrTG411B
EMDN: W0101060105
EMDN description: TRIGLYCERIDE TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

Triglycerides Test Strips

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrTG401BUC
Basic UDI-DI: B-acrTG401BUC
Reference: acrTG401B
EMDN: W0101060105
EMDN description: TRIGLYCERIDE TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

Total Cholesterol Test Strips

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrTC411BT5
Basic UDI-DI: B-acrTC411BT5
Reference: acrTC411B
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

Total Cholesterol Test Strips

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrTC401BSY
Basic UDI-DI: B-acrTC401BSY
Reference: acrTC401B
EMDN: W0101060102
EMDN description: CHOLESTEROL TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

High-density Lipoprotein Test Strips

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrHDL411BZ9
Basic UDI-DI: B-acrHDL411BZ9
Reference: acrHDL411B
EMDN: W0101060103
EMDN description: HDL TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

High-density Lipoprotein Test Strips

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrHDL401BZ4
Basic UDI-DI: B-acrHDL401BZ4
Reference: acrHDL401B
EMDN: W0101060103
EMDN description: HDL TEST STRIPS
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrCAL601GVY
Basic UDI-DI: B-acrCAL601GVY
Reference: acrCAL601G
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details