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55 device results listed.

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biotical Rotavirus Positive control (1u)

biotical Rotavirus Positive control (1u) / 1 unidad de hisopo de control positivo Rotavirus.

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942144628
Basic UDI-DI: B-84365942144628
Reference: CPRT01R
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:02

Manufacturer products View details

GENEDIA W COVID-19 Ag External Control Swab

GENEDIA W COVID-19 Ag External Control Swab

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: GC Medical Science Corporation
Manufacturer SRN: KR-MF-000015840
UDI-DI: 08806134656319
Basic UDI-DI: B-08806134656319
Reference: 563G
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 10.07.2026 09:07

Manufacturer products Authorised representative products Authorised representative actors View details

Mycobacterium Tuberculosis Nucleic Acid Assay Control

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120479
Basic UDI-DI: B-06975327120479
Reference: CRM1010602-1
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Nucleic Acid Assay Control

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120318
Basic UDI-DI: B-06975327120318
Reference: CRM1010402-1
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Assay Control

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Guangzhou Pluslife Biotech Co., Ltd
Manufacturer SRN: CN-MF-000025784
UDI-DI: 06975327120271
Basic UDI-DI: B-06975327120271
Reference: CRM1010302-1
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Germany
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:28

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus (MPxV) Antigen Quality Control

Monkeypox Virus (MPxV) Antigen Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521008057
Basic UDI-DI: B-06974521008057
Reference: QC60401
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY/NAT - RT & POC
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus (MPxV) Antigen Quality Control

Monkeypox Virus (MPxV) Antigen Quality Control

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Superbio Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000024149
UDI-DI: 06974521008064
Basic UDI-DI: B-06974521008064
Reference: QC60402
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY/NAT - RT & POC
First on market country: Ireland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

Positive control swab Adenovirus & Rotavirus

Positive control swab Adenovirus & Rotavirus

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532678594101
Basic UDI-DI: B-03532678594101
Reference: SW4019
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:47

Manufacturer products Authorised representative products Authorised representative actors View details

H. Pylori positive control

PYLORI positive Control

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670502562
Basic UDI-DI: B-03532670502562
Reference: 6030002
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

NOROVIRUS GII positive Control

NOROVIRUS GII positive Control

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670502463
Basic UDI-DI: B-03532670502463
Reference: 6150002
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

Norovirus GI Positive Control

NOROVIRUS GI positive Control

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670502449
Basic UDI-DI: B-03532670502449
Reference: 6150001
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

Positive control swab COVID-19 Ag

Positive control swab COVID-19 Ag

IVD generalIVDDOn the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532670501084
Basic UDI-DI: B-03532670501084
Reference: SW40009
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:38

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI T. pallidum Test Controls

90-1032

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testing

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597202128
Basic UDI-DI: B-00686597202128
Reference: 90-1032
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HCV Test Controls

90-1067

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testing

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200766
Basic UDI-DI: B-00686597200766
Reference: 90-1067
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

Manufacturer products Authorised representative products Authorised representative actors View details

INSTI HIV-1/HIV-2 Test Controls

90-1036

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testing

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200513
Basic UDI-DI: B-00686597200513
Reference: 90-1036
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:03

Manufacturer products Authorised representative products Authorised representative actors View details