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907 device results listed.

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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

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

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

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

Typhoid Antigen Test Kit(Feces)

TYP0086

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610214
Basic UDI-DI: B-86979834610214
Reference: TYP0086
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

H.pylori Antigen Test Kit(Feces)

HPG0021

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610153
Basic UDI-DI: B-86979834610153
Reference: HPG0021
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

H.pylori Antibody Test Kit(Serum/plasma/whole blood)

HPB0020

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610108
Basic UDI-DI: B-86979834610108
Reference: H.pylori Antibody Test Kit(Serum/plasma/whole blood)
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

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

SYP0052

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610085
Basic UDI-DI: B-86979834610085
Reference: SYP0052
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

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

TYP0085

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610061
Basic UDI-DI: B-86979834610061
Reference: TYP0085
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

biotical Yersinia enterocolitica O:3 Card (+PC +NC)

biotical Yersinia enterocolitica O:3 Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:3 +1 C. Negativo universal)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942152166
Basic UDI-DI: B-84365942152166
Reference: RTB25Y3CN
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:12

Manufacturer products View details

biotical Yersinia enterocolitica O:3 Card (+PC)

biotical Yersinia enterocolitica O:3 Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:3)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942152098
Basic UDI-DI: B-84365942152098
Reference: RTB25Y3C
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:12

Manufacturer products View details

biotical Yersinia enterocolitica O:3 Card

biotical Yersinia enterocolitica O:3 Card / 25 test rápidos con viales para muestra fecal (sin controles externos).

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942151930
Basic UDI-DI: B-84365942151930
Reference: RTB25Y3
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:12

Manufacturer products View details

biotical Yersinia enterocolitica O:9 Card (+PC +NC)

biotical Yersinia enterocolitica O:9 Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:9 +1 C. Negativo universal)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942151626
Basic UDI-DI: B-84365942151626
Reference: RTB25Y9CN
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:12

Manufacturer products View details

biotical Yersinia enterocolitica O:9 Card (+PC)

biotical Yersinia enterocolitica O:9 Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo Yersinia enterocolitica O:9)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942151558
Basic UDI-DI: B-84365942151558
Reference: RTB25Y9C
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:12

Manufacturer products View details