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55 device results listed.

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LyoSens™

LYO61WS96

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805706
Basic UDI-DI: 868511580PCR61JE
Reference: LYO61WS96
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 04:19

Manufacturer products View details

Detection Kit for 2019-nCOV,Influenza A Virus and Influenza B Virus（PCR Fluorescence Probe）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: SINGUWAY BIOTECH INC.
Manufacturer SRN: CN-MF-000027180
UDI-DI: 06974081870422
Basic UDI-DI: B-06974081870422
Reference: CFP001
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Greece
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:44

Manufacturer products Authorised representative products Authorised representative actors View details

06955792735644

Poliovirus type 1, type 2, and type 3 Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792735644
Basic UDI-DI: B-06955792735644
Reference: S3271E-48
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 22:10

Manufacturer products Authorised representative products Authorised representative actors View details

Virus RNA Collection Kit

IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260212446
Basic UDI-DI: B-06933260212446
Reference: /
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 31.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

112009491923

SwiftX Virus

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Xpedite Diagnostics GmbH
Manufacturer SRN: DE-MF-000020021
UDI-DI: 112009491923
Basic UDI-DI: PP12579SWIFTX.VIRUS30
Reference: SXV-50-IVD
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:39

Manufacturer products View details

111917795923

EUROArray SwiftX-traction

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Xpedite Diagnostics GmbH
Manufacturer SRN: DE-MF-000020021
UDI-DI: 111917795923
Basic UDI-DI: PP12579SWIFTX.EUROARRAY49
Reference: SXEA-50-IVD
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:38

Manufacturer products View details

112011809224

IVD Class AIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Xpedite Diagnostics GmbH
Manufacturer SRN: DE-MF-000020021
UDI-DI: 112011809224
Basic UDI-DI: PP12579SWIFTX.VIRUS30
Reference: EBE-078-200
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: -
Authorised representative: -
Last updated: 14.07.2026 22:49

Manufacturer products View details

GA-map® COVID-19 Fecal Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genetic Analysis AS
Manufacturer SRN: NO-MF-000023768
UDI-DI: D-101099
Basic UDI-DI: B-101099
Reference: 1010
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Norway
Authorised representative: -
Last updated: 11.07.2026 00:38

Manufacturer products View details

SOFTEC Human Papillomavirus (HPV) High Risk Panel Qualitative RT-qPCR Detection Kit

TUBE

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.
Manufacturer SRN: TR-MF-000046897
UDI-DI: 08697962616596
Basic UDI-DI: B-08697962616596
Reference: ZT-HPV-01-100
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 09.07.2026 07:22

Manufacturer products View details

Adenovirus/RSV Combo Rapid Test

GIADR

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762357
Basic UDI-DI: B-06976202762357
Reference: GIADR-722
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Nucleic Acid Rapid Test

GE-RC4

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai GeneSc Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029293
UDI-DI: 06975412190103
Basic UDI-DI: B-06975412190103
Reference: GZ-SC96
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Nucleic Acid Rapid Test

GE-RC4

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai GeneSc Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029293
UDI-DI: 06975412190097
Basic UDI-DI: B-06975412190097
Reference: GZ-SC4
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Nucleic Acid Rapid Test

GE-RC4

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai GeneSc Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029293
UDI-DI: 06975412190080
Basic UDI-DI: B-06975412190080
Reference: GZ-SC1
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus 2019-nCoV Rapid Detection Kit (LAMP)

GE-RT96

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai GeneSc Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029293
UDI-DI: 06975412190073
Basic UDI-DI: B-06975412190073
Reference: GZ-OX96
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

Novel Coronavirus 2019-nCoV Rapid Detection Kit (LAMP)

GE-RT96

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shanghai GeneSc Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029293
UDI-DI: 06975412190066
Basic UDI-DI: B-06975412190066
Reference: GZ-OX48
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 22:34

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox virus nucleic acid real-time PCR detection kit

MV02-Y32

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689627220
Basic UDI-DI: B-06974689627220
Reference: 13802
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox virus nucleic acid real-time PCR detection kit

MV01-1Y32

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689627213
Basic UDI-DI: B-06974689627213
Reference: 13801
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

JCV/BKV nucleic acid digital PCR detection kit

JB01-Y24

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689627183
Basic UDI-DI: B-06974689627183
Reference: 13786-2
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:27

Manufacturer products Authorised representative products Authorised representative actors View details

JCV/BKV nucleic acid digital PCR detection kit

JB01-Q24

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: TargetingOne Technology (Beijing) Corporation
Manufacturer SRN: CN-MF-000028247
UDI-DI: 06974689626346
Basic UDI-DI: B-06974689626346
Reference: 13786-1
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

Monkeypox Virus Nuclear Acid Detection Kit (Real Time PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Shanghai GeneoDx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000029299
UDI-DI: 06974593880124
Basic UDI-DI: B-06974593880124
Reference: GZ-MPV100
EMDN: W01050499
EMDN description: VIROLOGY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.07.2026 20:00

Manufacturer products Authorised representative products Authorised representative actors View details