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Rapid COVID-19 Antigen Self-Test

GCCOV-502a-H10

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCCOV-502a-H10GE
Basic UDI-DI: B-GCCOV-502a-H10GE
Reference: GCCOV-502a-H10
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:24

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B-Q Real Time PCR Kit

G2M706021

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M706021F5
Basic UDI-DI: B-G2M706021F5
Reference: G2M706021, G2M706021R
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

VZV-Q Real-Time PCR Kit for Varicella-zoster virus

G2M705821

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagent

Manufacturer: Genes 2Me Private Limited
Manufacturer SRN: IN-MF-000035953
UDI-DI: D-G2M705821G6
Basic UDI-DI: B-G2M705821G6
Reference: G2M705821,G2M705821R
EMDN: W0105099006
EMDN description: VZV - RT & POC
First on market country: Belgium
Authorised representative: Obelis s.a.
Last updated: 13.07.2026 23:43

Manufacturer products Authorised representative products Authorised representative actors View details

CerTest Rotavirus+Adenovirus+Astrovirus

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440205999
Basic UDI-DI: 84354402IDXGASTROB_RT8H
Reference: RT872001VC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 22:59

Manufacturer products View details

CerTest Rotavirus+Adenovirus+Astrovirus

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440207641
Basic UDI-DI: 84354402IDXGASTROB_RT8H
Reference: RT872001VCC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 22:59

Manufacturer products View details

CerTest Rotavirus+Adenovirus

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440206057
Basic UDI-DI: 84354402IDXGASTROB_XR8X
Reference: XR882001VC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 22:59

Manufacturer products View details

CerTest Rotavirus+Adenovirus

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440207740
Basic UDI-DI: 84354402IDXGASTROB_XR8X
Reference: XR882001VCC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 22:58

Manufacturer products View details

CerTest Astrovirus

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440201458
Basic UDI-DI: 84354402IDXGASTROB_AT6W
Reference: AT820001VC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 22:55

Manufacturer products View details

CerTest Astrovirus

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: CERTEST BIOTEC S.L.
Manufacturer SRN: ES-MF-000002193
UDI-DI: 08435440207344
Basic UDI-DI: 84354402IDXGASTROB_AT6W
Reference: AT820001VCC
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Authorised representative: -
Last updated: 13.07.2026 22:55

Manufacturer products View details

Influenza A+B Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-FLU-B22bGV
Basic UDI-DI: B-FLU-B22bGV
Reference: FLU-B22b
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 13.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B Antigen Rapid Test

FLU-522b

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-FLU-522bE9
Basic UDI-DI: B-FLU-522bE9
Reference: FLU-522b
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Llins Service & Consulting GmbH
Last updated: 13.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-FIMF16823COV7S67

Salocor SARS-CoV-2 Antigen Rapid Test Cassette (Nasal Swab)