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Vibrio cholerae O1/O139 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-IVCAB-R6258V
Basic UDI-DI: B-IVCAB-R6258V
Reference: IVCAB-R625
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio cholerae O1 (VC O1) Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IVCA-R6029G
Basic UDI-DI: B-IVCA-R6029G
Reference: IVCA-R602
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IVC-R635JF
Basic UDI-DI: B-IVC-R635JF
Reference: IVC-R635
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IVC-R602HY
Basic UDI-DI: B-IVC-R602HY
Reference: IVC-R602
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:06

Manufacturer products Authorised representative products Authorised representative actors View details

Scrub Typhus 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-ITSU-R402QL
Basic UDI-DI: B-ITSU-R402QL
Reference: ITSU-R402
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:05

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISB-R502FT
Basic UDI-DI: B-ISB-R502FT
Reference: ISB-R502
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:04

Manufacturer products Authorised representative products Authorised representative actors View details

Multiplex Respiratory Antigen Rapid Test (Flu B/Flu A/HPIV 1/3/HPIV 2/HMPV/Adeno/MP/RSV/COVID-19)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IRTC-595(SSW)F9
Basic UDI-DI: B-IRTC-595(SSW)F9
Reference: IRTC-595(SSW)
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Italy
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:04

Manufacturer products Authorised representative products Authorised representative actors View details

D-HIFL-522E6

Influenza A+B Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: D-HIFL-522E6
Basic UDI-DI: B-HIFL-522E6
Reference: HIFL-522
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Czechia
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid COVID-19 (Antigen) Self-Test

GCCOV-502a-H2OGE

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCCOV-502a-H2OGEEW
Basic UDI-DI: B-GCCOV-502a-H2OGEEW
Reference: GCCOV-502a-H2OGE
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 05:03

Manufacturer products Authorised representative products Authorised representative actors View details

D-A5399

INDICAID™ Respiratory 12-in-1 Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A5399
Basic UDI-DI: B-A5399
Reference: INDICAID™ Respiratory 12-in-1 Rapid Antigen Test
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A5195

INDICAID™ HPV Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A5195
Basic UDI-DI: B-A5195
Reference: INDICAID™ HPV Rapid Antigen Test
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A5297

INDICAID™ Respiratory 12-in-1 Rapid Antigen Test (Children Edition)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A5297
Basic UDI-DI: B-A5297
Reference: INDICAID™ Respiratory 12-in-1 Rapid Antigen Test (Children Edition)
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A067DF

INDICAID™ Chikungunya Rapid Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A067DF
Basic UDI-DI: B-A067DF
Reference: INDICAID™ Chikungunya Rapid Antibody Test
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A066DD

INDICAID™ Chikungunya Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A066DD
Basic UDI-DI: B-A066DD
Reference: INDICAID™ Chikungunya Rapid Antigen Test
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A056DA

INDICAID™ Helicobacter pylori Rapid IgG Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A056DA
Basic UDI-DI: B-A056DA
Reference: INDICAID™ Helicobacter pylori Rapid IgG Antibody Test
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A055D8

INDICAID™ Helicobacter pylori Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A055D8
Basic UDI-DI: B-A055D8
Reference: INDICAID™ Helicobacter pylori Rapid Antigen Test
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-A043CZ

INDICAID™ Ureaplasma Urealyticum Rapid Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A043CZ
Basic UDI-DI: B-A043CZ
Reference: INDICAID™ Ureaplasma Urealyticum Rapid Antibody Test
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-A042CX

INDICAID™ HPV Virus Staining Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A042CX
Basic UDI-DI: B-A042CX
Reference: INDICAID™ HPV Virus Staining Test
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:42

Manufacturer products Authorised representative products Authorised representative actors View details

D-A040CT

INDICAID™ Respiratory 6-in-1 Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A040CT
Basic UDI-DI: B-A040CT
Reference: INDICAID™ Respiratory 6-in-1 Rapid Antigen Test
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:41

Manufacturer products Authorised representative products Authorised representative actors View details

D-A039DA

INDICAID™ Multiple Respiratory Pathogen Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A039DA
Basic UDI-DI: B-A039DA
Reference: INDICAID™ Multiple Respiratory Pathogen Rapid Antigen Test
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:41

Manufacturer products Authorised representative products Authorised representative actors View details