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22.09.2026 04:45

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452 device results listed.

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0510

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357012309
Basic UDI-DI: 0845357005109G
Reference: [0510U] KWIK-STIK™ C. krusei ATCC 34135™
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:12

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0500

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357012026
Basic UDI-DI: 0845357005009D
Reference: [0500U] KWIK-STIK™ A. niger ATCC 6275™
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:12

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0450

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357010497
Basic UDI-DI: 0845357004509P
Reference: [0450U] KWIK-STIK™ C. tropicalis ATCC 13803™
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:11

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0444

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357010350
Basic UDI-DI: 0845357004449U
Reference: [0444U] KWIK-STIK™ T. rubrum ATCC 28188™
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:11

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0443

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357010299
Basic UDI-DI: 0845357004439S
Reference: [0443U] KWIK-STIK™ C. albicans ATCC 10231™
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:11

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0442

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357010237
Basic UDI-DI: 0845357004429Q
Reference: [0442U] KWIK-STIK™ T. interdigitale ATCC 9533™
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:11

Manufacturer products Authorised representative products Authorised representative actors View details

0425

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357009781
Basic UDI-DI: 0845357004259Q
Reference: [0425U] KWIK-STIK™ C. albicans ATCC 60193™
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:11

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0227

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357003628
Basic UDI-DI: 0845357002279J
Reference: [0227U] KWIK-STIK™ I. orientalis ATCC 6258™
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 30.07.2026 20:10

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McFarland Standard

McFarland Standard

IVD Class AIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026100087
Basic UDI-DI: 357302BUDI000502T7
Reference: 70900
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: France
Authorised representative: -
Last updated: 21.07.2026 22:50

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RPR-VDRL-TPHA negative control

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873209250
Basic UDI-DI: B-84352873209250
Reference: 2925805
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 04:32

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RPR-VDRL positive control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873209175
Basic UDI-DI: B-84352873209175
Reference: 2925105
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 17.07.2026 04:32

Manufacturer products View details

Calibrator for use with AUTOF MS

refer to IFU

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06970150908256
Basic UDI-DI: B-06970150908256
Reference: MSA02
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 18:58

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MM94 Selectrol® Aspergillus brasiliensis NCPF® 2275 / ATCC® 16404

MM94

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingSingle use

Manufacturer: TCS Biosciences Limited
Manufacturer SRN: UK-MF-000055784
UDI-DI: 05053419016440
Basic UDI-DI: B-05053419016440
Reference: MM94
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: Netherlands
Authorised representative: TCS Biosciences EU BV
Last updated: 16.07.2026 17:38

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MM25 Selectrol® Acinetobacter baumannii NCTC® 12156 / ATCC® 19606

MM25 Acinetobacter baumannii NCTC® 12156 / ATCC® 19606

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingSingle use

Manufacturer: TCS Biosciences Limited
Manufacturer SRN: UK-MF-000055784
UDI-DI: 05053419015818
Basic UDI-DI: B-05053419015818
Reference: MM25
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: Netherlands
Authorised representative: TCS Biosciences EU BV
Last updated: 16.07.2026 17:38

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ESR Control Level 2

ESR Control Level 2

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.
Manufacturer SRN: TR-MF-000021882
UDI-DI: 08680952301275
Basic UDI-DI: 8680952301CESR29V
Reference: CESR 2
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 16.07.2026 12:34

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ESR Control Level 1

ESR Control Level 1

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.
Manufacturer SRN: TR-MF-000021882
UDI-DI: 08680952301268
Basic UDI-DI: 8680952301CESR19T
Reference: CESR 1
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 16.07.2026 12:34

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CP-2 Coagulation Control Plasma Level 2

CP-2 Coagulation Control Plasma Level 2

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.
Manufacturer SRN: TR-MF-000021882
UDI-DI: 08680952301176
Basic UDI-DI: 8680952301Level-2SM
Reference: Level-2
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 16.07.2026 12:34

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CP-1 Coagulation Control Plasma Level 1

CP-1 Coagulation Control Plasma Level 1

IVD Class AIVDR 2017/746On the marketDirect marking

Manufacturer: Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.
Manufacturer SRN: TR-MF-000021882
UDI-DI: 08680952301169
Basic UDI-DI: 8680952301Level-1SK
Reference: Level-1
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 16.07.2026 12:34

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-

IVD Class BNot specifiedOn the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357003642
Basic UDI-DI: 0845357002279J
Reference: [0227L] LYFO DISK™ I. orientalis ATCC 6258™
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 07:57

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-

IVD Class BNot specifiedOn the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357009804
Basic UDI-DI: 0845357004259Q
Reference: [0425L] LYFO DISK™ C. albicans ATCC 60193™
EMDN: W01040699
EMDN description: CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 07:47

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