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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-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

Tetanos Quick Stick

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Eurobio Scientific
Manufacturer SRN: FR-MF-000011745
UDI-DI: D-TE20B/S-GZ-20BQU
Basic UDI-DI: B-TE20B/S-GZ-20BQU
Reference: TE20B / S-GZ-20B
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: France
Authorised representative: -
Last updated: 23.07.2026 19:57

Manufacturer products View details

Salmonella typhi and paratyphi Antigen Control

IVD generalIVDDOn the marketProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-SCSTP-DC9
Basic UDI-DI: B-SCSTP-DC9
Reference: SCSTP-D
EMDN: W0105094001
EMDN description: CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 23.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

Filariasis IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IFIL-402E2
Basic UDI-DI: B-IFIL-402E2
Reference: IFIL-402
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details

Filariasis IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IFIL-302DV
Basic UDI-DI: B-IFIL-302DV
Reference: IFIL-302
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue NS1 Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IDES-R4026U
Basic UDI-DI: B-IDES-R4026U
Reference: IDES-R402
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IDEN-R4024T
Basic UDI-DI: B-IDEN-R4024T
Reference: IDEN-R402
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 00:49

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Device

Strip, Device

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804804558
Basic UDI-DI: 69528048A463101ZT
Reference: A4631011
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Device

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804837174
Basic UDI-DI: 69528048A463101ZT
Reference: A4631021
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HCV Rapid Antibody Test

1001-0371

IVD Annex II List AIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: D-1001-0371C2
Basic UDI-DI: B-1001-0371C2
Reference: 1001-0371
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HCV Rapid Antibody Test

1001-0370

IVD Annex II List AIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: D-1001-0370BY
Basic UDI-DI: B-1001-0370BY
Reference: 1001-0370
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: -
Authorised representative: QbD RepS BV
Last updated: 22.07.2026 06:49

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio cholerae O139 (VC O139) Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IVCB-602GY
Basic UDI-DI: B-IVCB-602GY
Reference: IVCB-602
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details