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MM GRAM NEG RES

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

Manufacturer: Alifax S.r.l.
Manufacturer SRN: IT-MF-000030029
UDI-DI: 08056040149331
Basic UDI-DI: 805604014SI1701.0101LA
Reference: SI 1701.0101/L
EMDN: W0104080699
EMDN description: NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 12.08.2026 23:33

Manufacturer products View details

MM GRAM POS NO STAPH

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

Manufacturer: Alifax S.r.l.
Manufacturer SRN: IT-MF-000030029
UDI-DI: 08056040149263
Basic UDI-DI: 805604014SI1701.0104LG
Reference: SI 1701.0104/L
EMDN: W0104080699
EMDN description: NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 12.08.2026 23:33

Manufacturer products View details

HB&L CARBAPENEMASE KIT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Alifax S.r.l.
Manufacturer SRN: IT-MF-000030029
UDI-DI: 08056040149300
Basic UDI-DI: 805604015SI1001.930B9
Reference: SI 1001.950
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Italy
Authorised representative: -
Last updated: 12.08.2026 23:33

Manufacturer products View details

MM GRAM POS STAPH

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

Manufacturer: Alifax S.r.l.
Manufacturer SRN: IT-MF-000030029
UDI-DI: 08056040149256
Basic UDI-DI: 805604014SI1701.0103LE
Reference: SI 1701.0103/L
EMDN: W0104080699
EMDN description: NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 12.08.2026 23:33

Manufacturer products View details

ChainFor™

CFP88

IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257857
Basic UDI-DI: B-08683548257857
Reference: PCR60
EMDN: W0104080207
EMDN description: MYCOPLASMA / UREAPLASMA - (INCL. COMBINED ID-AST)
First on market country: Germany
Authorised representative: -
Last updated: 12.08.2026 22:49

Manufacturer products View details

SENSITITRE FR2STENT

Sensititre FR2STENT

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384565733
Basic UDI-DI: 5032384FR2STENTUK
Reference: FR2STENT
EMDN: W0104080599
EMDN description: MANUAL SUSCEPTIBILITY TESTING - OTHER
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 11.08.2026 22:59

Manufacturer products Authorised representative products Authorised representative actors View details

Sensititre IRBP11F

Sensititre™ IRBP11F

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Trek Diagnostic Systems Ltd
Manufacturer SRN: GB-MF-000016922
UDI-DI: 05032384565740
Basic UDI-DI: 5032384IRBP11FKY
Reference: Sensititre™ IRBP11F
EMDN: W0104080107
EMDN description: GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 11.08.2026 22:57

Manufacturer products Authorised representative products Authorised representative actors View details

U-CardDx™ 200

Carba Test

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289854054
Basic UDI-DI: B-06933289854054
Reference: WR88P0001
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
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

Carba Test

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289854061
Basic UDI-DI: B-06933289854061
Reference: WR88P0002
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 18:19

Manufacturer products Authorised representative products Authorised representative actors View details

OXA-23 carbapenemase Test Kit (LFIA)

124113-20-161

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-124113-20-161D8
Basic UDI-DI: B-124113-20-161D8
Reference: 124113-20-161
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 05.08.2026 15:26

Manufacturer products Authorised representative products Authorised representative actors View details

OXA-23 carbapenemase Test Kit (LFIA)

124113-01-161

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-124113-01-161CR
Basic UDI-DI: B-124113-01-161CR
Reference: 124113-01-161
EMDN: W0104080506
EMDN description: TARGETED RESISTANCE TESTS - CARBAPENEMASE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 05.08.2026 15:26

Manufacturer products Authorised representative products Authorised representative actors View details

U-Card™ 200

Carba Test

IVD generalIVDDNo longer on the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000000689
UDI-DI: 06933289854078
Basic UDI-DI: B-06933289854078
Reference: WR88P0003
EMDN: W0104080606
EMDN description: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 05.08.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

BACTEROMIC Syringe Plug

IVD Class AIVDR 2017/746On the marketProfessional testingSingle use

Manufacturer: BACTEROMIC SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ
Manufacturer SRN: PL-MF-000040114
UDI-DI: 05905721780000
Basic UDI-DI: 59047268494SPDA
Reference: BQS-520012
EMDN: W0104080113
EMDN description: OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...)
First on market country: Poland
Authorised representative: -
Last updated: 04.08.2026 21:49

Manufacturer products View details

ChainFor™

CFP189P100