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HMPV Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IHMPV-ACO502UU
Basic UDI-DI: B-IHMPV-ACO502UU
Reference: IHMPV-ACO502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 28.07.2026 01:05

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IFLA-502BM
Basic UDI-DI: B-IFLA-502BM
Reference: IFLA-502
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

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Influenza A Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IFLA-501BK
Basic UDI-DI: B-IFLA-501BK
Reference: IFLA-501
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 28.07.2026 01:05

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Συνδυαστικό τεστ ταχείας ανίχνευσης αντιγόνου του COVID-19 και της Ινφλουέντζας A+B Για αυτοδοκιμή

COVID-19 & Influenza A+B Antigen Combo Rapid Test

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: 06974246461144
Basic UDI-DI: B-06974246461144
Reference: FCO-6032H
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Greece
Authorised representative: Share info GmbH
Last updated: 28.07.2026 00:38

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S. pneumoniae Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISP-R102LV
Basic UDI-DI: B-ISP-R102LV
Reference: ISP-R102
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:37

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S. pneumoniae and L. pneumophila Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISLC-R125CV
Basic UDI-DI: B-ISLC-R125CV
Reference: ISLC-R125
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:37

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Legionella pneumophila Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ILEG-R10269
Basic UDI-DI: B-ILEG-R10269
Reference: ILEG-R102
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:36

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Syphilis Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISY-R302QU
Basic UDI-DI: B-ISY-R302QU
Reference: ISY-R302
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:44

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Syphilis Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISY-40125
Basic UDI-DI: B-ISY-40125
Reference: ISY-401
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:44

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Syphilis Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISY-301ZV
Basic UDI-DI: B-ISY-301ZV
Reference: ISY-301
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:44

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Strep A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISTB-R502GY
Basic UDI-DI: B-ISTB-R502GY
Reference: ISTB-R502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:44

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISTB-502N5
Basic UDI-DI: B-ISTB-502N5
Reference: ISTB-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:44

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISTB-501N3
Basic UDI-DI: B-ISTB-501N3
Reference: ISTB-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:44

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IST-R502P5
Basic UDI-DI: B-IST-R502P5
Reference: IST-R502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:44

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-STA-502X9
Basic UDI-DI: B-FI-STA-502X9
Reference: FI-STA-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Candida/Trichomonas Vaginalis/Gardnerella Vaginalis Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A078DL
Basic UDI-DI: B-A078DL
Reference: P0191
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 18:17

Manufacturer products Authorised representative products Authorised representative actors View details

H&W Eight Respiratory Pathogen Antigen Rapid Test Kit (LFIA)

123145-01-102 123145-02-102 123145-05-102 123145-20-102

IVD Class CIVDR 2017/746On the marketDirect markingKitSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167892393
Basic UDI-DI: 697416789123145ZT
Reference: HW-8combo-2026-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Safety summary (SSCP/SSP): 2 · Rev. A/2
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 24.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

H&W SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)

123143-01-102 123143-02-102 123143-05-102 123143-20-102

IVD Class DIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesSelf testingSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: 06974167891631
Basic UDI-DI: 697416789100NQ
Reference: HW-5combo-2025-01
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Finland
Safety summary (SSCP/SSP): 1 · Rev. 1
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 24.07.2026 09:59

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Helicobacter pylori Antigen (Hp-Ag) Diagnostic Kit (Immunochromatographic Assay)

25 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762353
Basic UDI-DI: B-06971348762353
Reference: MF-80-25
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details

Helicobacter pylori Antigen (Hp-Ag) Diagnostic Kit (Immunochromatographic Assay)

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760946
Basic UDI-DI: B-06971348760946
Reference: MF-80-20
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 06:53

Manufacturer products Authorised representative products Authorised representative actors View details