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Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IMP-425UX
Basic UDI-DI: B-IMP-425UX
Reference: IMP-425
EMDN: W0105010802
EMDN description: MYCOPLASMA ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella pneumophila Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-LEG-102NV
Basic UDI-DI: B-FI-LEG-102NV
Reference: FI-LEG-102
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-SYP-4026D
Basic UDI-DI: B-FI-SYP-4026D
Reference: FI-SYP-402
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:43

Manufacturer products Authorised representative products Authorised representative actors View details

ChainFor™

Mycoplasma hominis qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032435
Basic UDI-DI: 868499827PCR56Y4
Reference: CFP56P25
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 24.07.2026 23:12

Manufacturer products View details

D-Z093686X

N/A

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z093686X
Basic UDI-DI: B-Z093686X
Reference: Z09368
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Austria
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details

D-Z043665Q

N/A

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-Z043665Q
Basic UDI-DI: B-Z043665Q
Reference: Z04366
EMDN: W0105010302
EMDN description: SYPHILIS ANTIBODY ASSAYS TOTAL
First on market country: Austria
Authorised representative: -
Last updated: 24.07.2026 22:51

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276740
Basic UDI-DI: 868499827PCR56Y4
Reference: LYO56WS24
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:49

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276788
Basic UDI-DI: 868499827PCR56Y4
Reference: LYO56WS48
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:49

Manufacturer products View details

LyoSens™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998276825
Basic UDI-DI: 868499827PCR56Y4
Reference: LYO56WS96
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:49

Manufacturer products View details

ChainFor™

IVD Class CNot specifiedOn the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595032510
Basic UDI-DI: 868499827PCR56Y4
Reference: CFP56P50
EMDN: W010501080302
EMDN description: UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 24.07.2026 22:49

Manufacturer products View details

STANDARD™ F Legionella Ag FIA

FLGN01G

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725623
Basic UDI-DI: 88001117IPCA01FA16W4
Reference: 10LEG20D
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 24.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Salmonella paratyphi Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISPT-602SU
Basic UDI-DI: B-ISPT-602SU
Reference: ISPT-602
EMDN: W0105011001
EMDN description: SALMONELLA ANTIGEN DETECTION
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Typhoid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-TYP-4026W
Basic UDI-DI: B-FI-TYP-4026W
Reference: FI-TYP-402
EMDN: W0105011002
EMDN description: SALMONELLA ANTIBODY ASSAYS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 00:41

Manufacturer products Authorised representative products Authorised representative actors View details

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

HWTS-EV032A

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369762
Basic UDI-DI: 697484936HWTS-EV032AYS
Reference: W0105011802
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369779
Basic UDI-DI: 697484936HWTS-EV032AYS
Reference: HWTS-EVO32HL
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Manufacturer SRN: CN-MF-000012807
UDI-DI: 06974849369786
Basic UDI-DI: 697484936HWTS-EV032AYS
Reference: HWTS-EVO32HO
EMDN: W0105011802
EMDN description: C.DIFFICILE TOXIN A/B DETECTION
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 23.07.2026 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® QuantiFERON®-TB Gold Plus II

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104395
Basic UDI-DI: 80567713110954A
Reference: 311095
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:40

Manufacturer products View details

LIAISON® Legionella Urinary Ag

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104203
Basic UDI-DI: 805677131160043
Reference: 311600
EMDN: W0105010501
EMDN description: LEGIONELLA ANTIGEN DETECTION
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

LIAISON® QuantiFERON®-TB Gold Plus

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771104180
Basic UDI-DI: 80567713110503L
Reference: 311050
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

LIAISON® QuantiFERON®-TB Gold Plus

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103282
Basic UDI-DI: B-08056771103282
Reference: 311010
EMDN: W0105010799
EMDN description: MYCOBACTERIA REAGENTS - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details