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04049095210068

RIDA®UNITY C. difficile

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: R-Biopharm AG
Manufacturer SRN: DE-MF-000007993
UDI-DI: 04049095210068
Basic UDI-DI: 4049095UN08350000SS
Reference: UN0835
EMDN: W0105011804
EMDN description: C.DIFFICILE BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 22:21

Manufacturer products View details

RapidFor™

Mycoplasma pneumoniae Test Kit

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277815
Basic UDI-DI: 868459503VMD82SC49
Reference: VMD82TD
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Türkiye
Authorised representative: -
Last updated: 21.09.2026 21:48

Manufacturer products View details

RapidFor™

VMD82

IVD Class BIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030370
Basic UDI-DI: 868459503VMD82SC49
Reference: VMD82SC
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 21:33

Manufacturer products View details

RapidFor™

IVD Class BNot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277822
Basic UDI-DI: 868459503VMD82SC49
Reference: VMD82SD
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:33

Manufacturer products View details

RapidFor™

IVD Class BNot specifiedOn the marketKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998277839
Basic UDI-DI: 868459503VMD82SC49
Reference: VMD82BC
EMDN: W0105010801
EMDN description: MYCOPLASMA ANTIGEN DETECTION
First on market country: -
Authorised representative: -
Last updated: 21.09.2026 21:33

Manufacturer products View details

RapidFor™

VMD27

IVD Class CIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941339
Basic UDI-DI: 868334794VMD27TD4B
Reference: VMD27TD
EMDN: W0105011001
EMDN description: SALMONELLA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: -
Last updated: 21.09.2026 20:43

Manufacturer products View details

S. TYPHI H

ANTIGENOS FEBRILES: S. typhi H

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155002984
Basic UDI-DI: B-18430155002984
Reference: 990188
EMDN: W0105011099
EMDN description: SALMONELLA REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.08.2026 22:50

Manufacturer products View details

S. PARATYPHI A H

ANTIGENOS FEBRILES: S. paratyphi A, H

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: QUIMICA CLINICA APLICADA S.A.
Manufacturer SRN: ES-MF-000001512
UDI-DI: 18430155003790
Basic UDI-DI: B-18430155003790
Reference: 999917
EMDN: W0105011099
EMDN description: SALMONELLA REAGENTS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 12.08.2026 22:50

Manufacturer products View details

HelicoSign Dry

HPYD050

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
UDI-DI: 08800076700451
Basic UDI-DI: B-08800076700451
Reference: HPYD050
EMDN: W0105010499
EMDN description: H. PYLORI REAGENTS - OTHER
First on market country: Germany
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 12.08.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

res3plex direct PCR

res1plex direct PCR

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: FRIZ Biochem GmbH
Manufacturer SRN: DE-MF-000017533
UDI-DI: 04260753890280
Basic UDI-DI: 426075389fbc121TY
Reference: FBC121
EMDN: W0105011105
EMDN description: STREP. PNEUMONIAE DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 11.08.2026 23:49

Manufacturer products View details

res2plex direct PCR

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: FRIZ Biochem GmbH
Manufacturer SRN: DE-MF-000017533
UDI-DI: 04260753890273
Basic UDI-DI: 426075389fbc120TW
Reference: FBC120
EMDN: W0105011607
EMDN description: BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 11.08.2026 23:49

Manufacturer products View details

LyoSens™

LYO58WS96

IVD Class CIVDDOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998275668
Basic UDI-DI: 868499827PCR58Y8
Reference: LYO58WS96
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 11.08.2026 23:01

Manufacturer products View details

Salmonella typhi Antigen Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISTY-602W7
Basic UDI-DI: B-ISTY-602W7
Reference: ISTY-602
EMDN: W0105011001
EMDN description: SALMONELLA ANTIGEN DETECTION
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 10.08.2026 06:56

Manufacturer products Authorised representative products Authorised representative actors View details

RealAccurate® Quadruplex Mycobacteria PCR kit

PF0920-R

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoFinder B.V.
Manufacturer SRN: NL-MF-000002704
UDI-DI: 08719326569963
Basic UDI-DI: B-08719326569963
Reference: PF0920-R
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

MeningoFinder® 2SMART

PF1200-2S

IVD Annex II List BIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoFinder B.V.
Manufacturer SRN: NL-MF-000002704
UDI-DI: 08719327116111
Basic UDI-DI: B-08719327116111
Reference: PF1200-2S
EMDN: W0105011103
EMDN description: STREP. A DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

RealAccurate® Quadruplex Atypical Bacteria PCR kit

PF0966-R

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: PathoFinder B.V.
Manufacturer SRN: NL-MF-000002704
UDI-DI: 08719327497944
Basic UDI-DI: B-08719327497944
Reference: PF0966-R
EMDN: W0105010503
EMDN description: LEGIONELLA DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: -
Last updated: 09.08.2026 02:57

Manufacturer products View details

D-CAMP-602aXW

Campylobacter Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Medotex Biotech (HangZhou) Co., Ltd.
Manufacturer SRN: CN-MF-000051631
UDI-DI: D-CAMP-602aXW
Basic UDI-DI: B-CAMP-602aXW
Reference: CAMP-602a
EMDN: W0105011401
EMDN description: CAMPYLOBACTER DIRECT ANTIGEN DETECTION
First on market country: Greece
Authorised representative: Llins Service & Consulting GmbH
Last updated: 08.08.2026 02:05

Manufacturer products Authorised representative products Authorised representative actors View details

LyoSens™

Neisseria gonorrhoeae qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258946
Basic UDI-DI: 868499827PCR47Y3
Reference: LYO47WS24
EMDN: W0105010203
EMDN description: GONOCOCCAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 07.08.2026 23:11

Manufacturer products View details

ChainFor™

Chlamydia trachomatis qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257741
Basic UDI-DI: 868511580PCR48JN
Reference: CFP48P100
EMDN: W0105010117
EMDN description: CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 07.08.2026 23:11

Manufacturer products View details

U-CardDx™ 200

C.difficile Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853927
Basic UDI-DI: B-06933289853927
Reference: WR89P0003
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details