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22.09.2026 16:13

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277 device results listed.

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LyoSens™

LYO82WS96

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115803450
Basic UDI-DI: 868511580PCR82JN
Reference: LYO82WS96
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 09:35

Manufacturer products View details

ChainFor™

MTB/non-TB Genotyping qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031308
Basic UDI-DI: 868511580PCR82JN
Reference: CFP82P25
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 22.09.2026 09:35

Manufacturer products View details

ChainFor™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032954
Basic UDI-DI: 868511580PCR82JN
Reference: CFP82P50
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:35

Manufacturer products View details

ChainFor™

CFP19

IVD Class CIVDDOn the marketCompanion diagnosticsInstrumentKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257246
Basic UDI-DI: 868511580PCR82JN
Reference: CFP82P100
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 09:35

Manufacturer products View details

RapidFor™

VMD37

IVD Class CIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683347941445
Basic UDI-DI: 868334794VMD37BD2U
Reference: VMD37BD
EMDN: W0105010702
EMDN description: MYCOBACTERIAL ANTIBODY ASSAYS
First on market country: Germany
Authorised representative: -
Last updated: 22.09.2026 01:48

Manufacturer products 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

U-Card™ 200

MTB&RIF Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850179
Basic UDI-DI: B-06933289850179
Reference: WR46P0009
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

MTB&RIF Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850162
Basic UDI-DI: B-06933289850162
Reference: WR46P0008
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

MTB&RIF Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850155
Basic UDI-DI: B-06933289850155
Reference: WR46P0007
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

04562185395280

TRCR MB-Lysis Reagent

IVD Class AIVDR 2017/746No longer on the marketProfessional testingReagent

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
UDI-DI: 04562185395280
Basic UDI-DI: 456018921000200273
Reference: 0056202
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Belgium
Authorised representative: Tosoh Europe N.V.
Last updated: 07.08.2026 18:18

Manufacturer products Authorised representative products Authorised representative actors View details

06975447582119

12 reactions/kit

IVD Class CIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Igenesis(Shanghai)Co.,Ltd.
Manufacturer SRN: CN-MF-000001552
UDI-DI: 06975447582119
Basic UDI-DI: 697544758MTB/RIF76
Reference: 106-0056-01
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 06.08.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

MTB Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853873
Basic UDI-DI: B-06933289853873
Reference: WE44P0001
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

MTB Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853880
Basic UDI-DI: B-06933289853880
Reference: WE44P0002
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDxTM 200

MTB Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289853897
Basic UDI-DI: B-06933289853897
Reference: WE44P0003
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:54

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

MTB INH&FQs Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850247
Basic UDI-DI: B-06933289850247
Reference: WR58P0004
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

MTB INH&FQs Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850254
Basic UDI-DI: B-06933289850254
Reference: WR58P0005
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

MTB INH&FQs Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289850261
Basic UDI-DI: B-06933289850261
Reference: WR58P0006
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

(TB) Tuberculosis Test

Strips & Cassette

IVD generalIVDDOn the marketKitProfessional testingReagentSelf testingSingle use

Manufacturer: Abiores Technology (Beijing) Co.,Ltd.
Manufacturer SRN: CN-MF-000022952
UDI-DI: 06958982140259
Basic UDI-DI: B-06958982140259
Reference: AB50-11
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Estonia
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 14:40

Manufacturer products Authorised representative products Authorised representative actors View details

FR013a-Mycobacterium tuberculosis-Doubel Check (Ready to use Realtime PCR-Kit)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genekam Biotechnology AG
Manufacturer SRN: DE-MF-000035227
UDI-DI: 04262420430003
Basic UDI-DI: B-04262420430003
Reference: FR013a
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 12:44

Manufacturer products View details

MTB Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Zeesan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000013246
UDI-DI: 06956299702979
Basic UDI-DI: B-06956299702979
Reference: 801219
EMDN: W0105010703
EMDN description: MYCOBACTERIAL DETECTION BY NA REAGENTS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 23:25

Manufacturer products Authorised representative products Authorised representative actors View details