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Accu-Tell® HAV IgM/IgG Strip(Serum/Plasma)

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A226UY
Basic UDI-DI: B-ABT-IDT-A226UY
Reference: ABT-IDT-B226
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® HAV IgM Strip (Serum/Plasma)

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A218UZ
Basic UDI-DI: B-ABT-IDT-A218UZ
Reference: ABT-IDT-A218
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-tell® Strep A Strip (Throat Swab)

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A15UF
Basic UDI-DI: B-ABT-IDT-A15UF
Reference: ABT-IDT-A15
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® H. pylori IgG Strip (Whole Blood/Serum/Plasma)

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A13UB
Basic UDI-DI: B-ABT-IDT-A13UB
Reference: ABT-IDT-A13
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:25

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ GASTROINTESTINAL 3-in-1 Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A031CS
Basic UDI-DI: B-A031CS
Reference: INDICAID™ GASTROINTESTINAL 3-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: 12.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Mycoplasma Pneumoniae (MP) Rapid IgM Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A017CY
Basic UDI-DI: B-A017CY
Reference: INDICAID™ Mycoplasma Pneumoniae (MP) Rapid IgM Antibody Test
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Mycoplasma Pneumoniae (MP) Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A016CW
Basic UDI-DI: B-A016CW
Reference: INDICAID™ Mycoplasma Pneumoniae (MP) Rapid Antigen Test
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Adenovirus Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A015CU
Basic UDI-DI: B-A015CU
Reference: INDICAID™ Adenovirus 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: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™Strep B Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A012CN
Basic UDI-DI: B-A012CN
Reference: INDICAID™Strep B Rapid Antigen Test
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Strep A Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A011CL
Basic UDI-DI: B-A011CL
Reference: INDICAID™ Strep A Rapid Antigen Test
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™ Rotavirus/Adenovirus Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A009CZ
Basic UDI-DI: B-A009CZ
Reference: INDICAID™ Rotavirus/Adenovirus 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: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-A007CV

INDICAID™ Dengue Virus Rapid Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A007CV
Basic UDI-DI: B-A007CV
Reference: INDICAID™ Dengue Virus Rapid Antibody Test
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-A006CT

INDICAID™Dengue Virus Rapid NS1 Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A006CT
Basic UDI-DI: B-A006CT
Reference: INDICAID™Dengue Virus Rapid NS1 Antigen Test
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-A005CR

INDICAID™ Respiratory 5-in-1 Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A005CR
Basic UDI-DI: B-A005CR
Reference: P0150, P0270
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

D-A004CP

P0098, P0099

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A004CP
Basic UDI-DI: B-A004CP
Reference: P0098
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-A003CM

INDICAID™Mycobacterium Tuberculosis Rapid IgG Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A003CM
Basic UDI-DI: B-A003CM
Reference: INDICAID™Mycobacterium Tuberculosis Rapid IgG Antibody Test
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-A001CH

INDICAID™Neisseria Gonorrhoeae (NGH) Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A001CH
Basic UDI-DI: B-A001CH
Reference: INDICAID™Neisseria Gonorrhoeae (NGH) Rapid Antigen Test
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

D-A002CK

INDICAID™Treponema Pallidum Rapid Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A002CK
Basic UDI-DI: B-A002CK
Reference: INDICAID™Treponema Pallidum Rapid Antibody Test
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:13

Manufacturer products Authorised representative products Authorised representative actors View details

Dr. Max Helicobacter pylori test

800017-x

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-888017SY
Basic UDI-DI: B-888017SY
Reference: 888017-1
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dr Max+

IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-888017-1ER
Basic UDI-DI: B-888017-1ER
Reference: 888017-1CRS
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Czechia
Authorised representative: QbD RepS BV
Last updated: 12.07.2026 20:29

Manufacturer products Authorised representative products Authorised representative actors View details