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226 device results listed.

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biotical E. Coli O157:H7 Card (+PC +NC)

biotical E. Coli O157:H7 Card (+PC +NC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo E. Coli O157:H7 +1 C. Negativo universal)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle useSterile

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942147452
Basic UDI-DI: B-84365942147452
Reference: RTB25ECN
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:03

Manufacturer products View details

biotical E. Coli O157:H7 Card (+PC)

biotical E. Coli O157:H7 Card (+PC) / 25 test rápidos con viales para muestra fecal (+1 C. Positivo E. Coli O157:H7)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: BIOTICAL HEALTH S.L.U
Manufacturer SRN: ES-MF-000018831
UDI-DI: 84365942147384
Basic UDI-DI: B-84365942147384
Reference: RTB25EC
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:03

Manufacturer products View details

biotical E. Coli O157:H7 Card

biotical E. Coli O157:H7 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: 84365942147216
Basic UDI-DI: B-84365942147216
Reference: RTB25E
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:03

Manufacturer products View details

Rapid Leptospira IgG/IgM Combo Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-1O23C2Y5
Basic UDI-DI: B-1O23C2Y5
Reference: 1O23C2-1-EU, 1O23C2-25-EU
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 11.07.2026 14:17

Manufacturer products Authorised representative products Authorised representative actors View details

B. pertussis Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698604161
Basic UDI-DI: B-16972698604161
Reference: P211106
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:53

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603720
Basic UDI-DI: B-16972698603720
Reference: P231119
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Shigella Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603706
Basic UDI-DI: B-16972698603706
Reference: P221110
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Vibrio cholerae O1/O139 Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603690
Basic UDI-DI: B-16972698603690
Reference: P221108
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Campylobacter Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603683
Basic UDI-DI: B-16972698603683
Reference: P221107
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Salmonella Typhi IgG/IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603645
Basic UDI-DI: B-16972698603645
Reference: P231118
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Salmonella Typhi Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603652
Basic UDI-DI: B-16972698603652
Reference: P221106
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

ReaScan+ LYME IgM/IgG Combo

RaeScan+ LYME IgM/IgG Combo

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: D-115103LV
Basic UDI-DI: B-115103LV
Reference: 115103
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:51

Manufacturer products View details

ReaScan+ C6 LYME IgG

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Reagena Oy
Manufacturer SRN: FI-MF-000002804
UDI-DI: D-114313M3
Basic UDI-DI: B-114313M3
Reference: 114313
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 05:48

Manufacturer products View details

LIODetect® TB-ST

LIODetect® TB-ST Tuberculosis Rapid Test

IVD generalIVDDOn the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Lionex GmbH
Manufacturer SRN: DE-MF-000038504
UDI-DI: 111418458750
Basic UDI-DI: B-111418458750
Reference: 3010_EN
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 11.07.2026 05:40

Manufacturer products View details

08693285187713

Tuberculosis (TB) Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187713
Basic UDI-DI: B-08693285187713
Reference: TITB01001
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:33

Manufacturer products View details

08693285187355

Tuberculosis (TB) Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187355
Basic UDI-DI: B-08693285187355
Reference: TITB01010
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:32

Manufacturer products View details

08693285187034

Tuberculosis (TB) Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285187034
Basic UDI-DI: B-08693285187034
Reference: TITB01
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:31

Manufacturer products View details

08693285183210

Tuberculosis (TB) Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285183210
Basic UDI-DI: B-08693285183210
Reference: ITB01
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:29

Manufacturer products View details

08693285183203

Tuberculosis (TB) Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285183203
Basic UDI-DI: B-08693285183203
Reference: RTTB01
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:29

Manufacturer products View details

08693285183197

Tuberculosis (TB) Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285183197
Basic UDI-DI: B-08693285183197
Reference: TTB01
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:29

Manufacturer products View details