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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

COVID 19 Antigen Test Kit (Colloidal Gold Method)

SVRAG89

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610580
Basic UDI-DI: B-86979834610580
Reference: SVRAG89
EMDN: W0105090501
EMDN description: CORONAVIRUS ANTIGEN (AG) - RT & POC
First on market country: Germany
Authorised representative: OSMUNDA Medical Technology Service GmbH
Last updated: 12.07.2026 17:23

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira lgG/lgM Test Kit(Serum/plasma/whole blood)

LEP0130

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610535
Basic UDI-DI: B-86979834610535
Reference: LEP0130
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:23

Manufacturer products Authorised representative products Authorised representative actors View details

Scrub Typhus IgG/IgM Test Kit(Serum/plasma/whole blood)

SCR0013

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610498
Basic UDI-DI: B-86979834610498
Reference: SCR0013
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Brucella Antibody Test Kit(Serum/plasma/whole blood)

BRU0048

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610474
Basic UDI-DI: B-86979834610474
Reference: BRU0048
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

SFTSV IgG/IgM Test Kit(Serum/plasma/whole blood)

SFT0082

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610450
Basic UDI-DI: B-86979834610450
Reference: SFT0082
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Shigella lgG/lgM Test Kit(Serum/plasma/whole blood)

SHI0179

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610436
Basic UDI-DI: B-86979834610436
Reference: SHI0179
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Vaginitis and Sexually Transmitted Infection Test Device(Urogenital Swab/Serum/plasma/whole blood)

VAG0243

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610399
Basic UDI-DI: B-86979834610399
Reference: VAG0243
EMDN: W0105090699
EMDN description: OTHER MULTIPLE PATHOGENS - RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis E Test Device(Serum/plasma/whole blood)

HEPE241

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610375
Basic UDI-DI: B-86979834610375
Reference: HEPE241
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Test Device(Serum/plasma/whole blood)

HEPA240

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610351
Basic UDI-DI: B-86979834610351
Reference: HEPA240
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria Test Device(whole blood)

MAL0238

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610313
Basic UDI-DI: B-86979834610313
Reference: MAL0238
EMDN: W0105090499
EMDN description: PARASITES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Zika Test Device (Serum/plasma/whole blood)

ZIK0237

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610290
Basic UDI-DI: B-86979834610290
Reference: Zika Test Device (Serum/plasma/whole blood)
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue Test Device(Serum/plasma/whole blood)

DEN0235

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610276
Basic UDI-DI: B-86979834610276
Reference: DEN0235
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

E.coli O157 Test Kit(Feces)

ECO0057

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610238
Basic UDI-DI: B-86979834610238
Reference: ECO0057
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Shigella Antigen Test Kit(Feces)

SHI0180

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610221
Basic UDI-DI: B-86979834610221
Reference: SHI0180
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details