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211 device results listed.

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SepsiTest™-UMD CE IVD

U-010-048

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testing

Manufacturer: Molzym GmbH & Co.KG
Manufacturer SRN: DE-MF-000037419
UDI-DI: D-U-010-0483K
Basic UDI-DI: B-U-010-0483K
Reference: U-010-048
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 11:25

Manufacturer products View details

Ureaplasma Urealyticum Real Time PCR Kit

-

IVD generalNot specifiedOn the market

Manufacturer: Jiangsu Bioperfectus Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000014691
UDI-DI: D-JB60103NW-50TS6
Basic UDI-DI: B-JB60103NW-50TS6
Reference: JB60103NW-50T
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 14.07.2026 03:22

Manufacturer products Authorised representative products Authorised representative actors View details

50 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BGI EUROPE A/S
Manufacturer SRN: DK-MF-000014089
UDI-DI: D-EU0100030050EN
Basic UDI-DI: B-EU0100030050EN
Reference: EU0100030050
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Denmark
Authorised representative: -
Last updated: 13.07.2026 21:08

Manufacturer products View details

D-81649002CMTBRIFZK01TFQX

CMTBRIFZK01-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CMTBRIFZK01TFQX
Basic UDI-DI: B-81649002CMTBRIFZK01TFQX
Reference: CMTBRIFZK01-AHG4E
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CMTBRIF01AT29X

CMTBRIF01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CMTBRIF01AT29X
Basic UDI-DI: B-81649002CMTBRIF01AT29X
Reference: CMTBRIF01A-AHG4E
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CMTBMDRZK01SVRN

CMTBMDRZK01-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CMTBMDRZK01SVRN
Basic UDI-DI: B-81649002CMTBMDRZK01SVRN
Reference: CMTBMDRZK01-AHG4E
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CMTBMDR01ARWB9

CMTBMDR01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CMTBMDR01ARWB9
Basic UDI-DI: B-81649002CMTBMDR01ARWB9
Reference: CMTBMDR01A-AHG4E
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:05

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002CMTB01AGXXR

CMTB01A-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002CMTB01AGXXR
Basic UDI-DI: B-81649002CMTB01AGXXR
Reference: CMTB01A-AHG4E
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHTV01GMRU

"AHTV01-AHG48E， AHTV01-AHG96E"

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002AHTV01GMRU
Basic UDI-DI: B-81649002AHTV01GMRU
Reference: "AHTV01-AHG48E， AHTV01-AHG96E"
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002AHTV01DJE35

AHTV01D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Life Science LLC
Manufacturer SRN: US-MF-000043017
UDI-DI: D-81649002AHTV01DJE35
Basic UDI-DI: B-81649002AHTV01DJE35
Reference: AHTV01D-AHG48E
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 10:00

Manufacturer products Authorised representative products Authorised representative actors View details

D-81649002ADZCOM01D7667

ADZCOM01D-AHG48E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-81649002ADZCOM01D7667
Basic UDI-DI: B-81649002ADZCOM01D7667
Reference: ADZCOM01D-AHG48E
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors View details

D-201059001020544Y

COVID-19 Nucleic Acid Detection Kit(Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Beijing Healthgene Laboratory Co.,Ltd
Manufacturer SRN: CN-MF-000032465
UDI-DI: D-201059001020544Y
Basic UDI-DI: B-201059001020544Y
Reference: 100 Tests/Kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

D-101059001020433G

COVID-19 Nucleic Acid Detection Kit(Fluorescence PCR)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Beijing Healthgene Laboratory Co.,Ltd
Manufacturer SRN: CN-MF-000032465
UDI-DI: D-101059001020433G
Basic UDI-DI: B-101059001020433G
Reference: 50 Tests/Kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 11.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens Haemophilus Ducreyi Detection qPCR Kit

LYO81

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595034958
Basic UDI-DI: B-08684595034958
Reference: LYO81
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:16

Manufacturer products View details

96 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166200233
Basic UDI-DI: B-06975166200233
Reference: 96 Tests/Kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

48 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166200226
Basic UDI-DI: B-06975166200226
Reference: 48 Tests/Kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

24 Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Avioq Bio-tech Co., Ltd.
Manufacturer SRN: CN-MF-000048146
UDI-DI: 06975166200219
Basic UDI-DI: B-06975166200219
Reference: 24 Tests/Kit
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 06.07.2026 22:01

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000050877
UDI-DI: 06975102441072
Basic UDI-DI: B-06975102441072
Reference: F03R10AⅢ-24
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 06.07.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000050877
UDI-DI: 06975102441065
Basic UDI-DI: B-06975102441065
Reference: F03R10AⅢ-48
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 06.07.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue Virus Nucleic Acid Detection Kit（Fluorescent RT-RAA）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Qitian Gene biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000050877
UDI-DI: 06975102441058
Basic UDI-DI: B-06975102441058
Reference: F03R10AⅢ-96
EMDN: W0105900102
EMDN description: REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS
First on market country: Germany
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 06.07.2026 21:58

Manufacturer products Authorised representative products Authorised representative actors View details