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Last updated

02.08.2026 18:51

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Active filter:EMDN:W01040699

422 device results listed.

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10845357037517

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IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
10845357037517
Basic UDI-DI
0845357001160WF
Reference
[01160L] LYFO DISK™ E. rubrum ATCC 42690™
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
-
Authorised representative
MediMark Europe Sarl.
Last updated
15.07.2026 10:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10845357037876

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IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
10845357037876
Basic UDI-DI
0845357001172WN
Reference
[01172L] LYFO DISK™ C. neoformans ATCC 13690™
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
-
Authorised representative
MediMark Europe Sarl.
Last updated
15.07.2026 10:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10845357037937

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IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
10845357037937
Basic UDI-DI
0845357001173WQ
Reference
[01173L] LYFO DISK™ C. neoformans (D) ATCC 36556™
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
-
Authorised representative
MediMark Europe Sarl.
Last updated
15.07.2026 10:17
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10845357038026

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IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
10845357038026
Basic UDI-DI
0845357001182WR
Reference
[01182L] LYFO DISK™ A. flavus ATCC 9643™
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
-
Authorised representative
MediMark Europe Sarl.
Last updated
15.07.2026 10:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10845357038118

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IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
10845357038118
Basic UDI-DI
0845357001185WX
Reference
[01185L] LYFO DISK™ C. kefyr ATCC 8553™
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
-
Authorised representative
MediMark Europe Sarl.
Last updated
15.07.2026 10:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10845357038613

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IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
10845357038613
Basic UDI-DI
0845357001200W2
Reference
[01200L] LYFO DISK™ P. rubens ATCC 11709™
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
-
Authorised representative
MediMark Europe Sarl.
Last updated
15.07.2026 10:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10845357040241

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IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
10845357040241
Basic UDI-DI
0845357001238WT
Reference
[01238U] KWIK-STIK™ T. pinophilus ATCC 11797™
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
-
Authorised representative
MediMark Europe Sarl.
Last updated
15.07.2026 10:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10845357040739

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IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
10845357040739
Basic UDI-DI
0845357001256WV
Reference
[01256U] KWIK-STIK™ C. auris CDC B11903
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
-
Authorised representative
MediMark Europe Sarl.
Last updated
15.07.2026 10:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10845357041699

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IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
10845357041699
Basic UDI-DI
0845357001264WU
Reference
[01264L] LYFO DISK™ A. terreus ATCC 1012™
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
-
Authorised representative
MediMark Europe Sarl.
Last updated
15.07.2026 10:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MYCOKIT CONTROL

MYCOKIT CONTROL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Eurobio Scientific
Manufacturer SRN
FR-MF-000011745
UDI-DI
D-PL10061N4
Basic UDI-DI
B-PL10061N4
Reference
PL10061
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
France
Authorised representative
-
Last updated
14.07.2026 09:45
Manufacturer productsView details
EurobioPlex DNA QC Control of DNA extraction and amplification

EurobioPlex DNA QC Control of DNA extraction and amplification

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Eurobio Scientific
Manufacturer SRN
FR-MF-000011745
UDI-DI
D-EBX-002Q4
Basic UDI-DI
B-EBX-002Q4
Reference
EBX-002
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
France
Authorised representative
-
Last updated
13.07.2026 18:27
Manufacturer productsView details
Progress Control Level 1

Progress Control Level 1

IVD generalIVDDOn the market
Manufacturer
Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.
Manufacturer SRN
TR-MF-000021882
UDI-DI
08680952301527
Basic UDI-DI
B-08680952301527
Reference
EPCL123
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
08.07.2026 12:28
Manufacturer productsView details
MPCP Multi Parameter Coagulation Calibrator

MPCP Multi Parameter Coagulation Calibrator

IVD generalIVDDOn the market
Manufacturer
Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.
Manufacturer SRN
TR-MF-000021882
UDI-DI
08680952301329
Basic UDI-DI
B-08680952301329
Reference
.
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
08.07.2026 12:28
Manufacturer productsView details
ESR Control Level 3

ESR Control Level 3

IVD generalIVDDOn the market
Manufacturer
Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.
Manufacturer SRN
TR-MF-000021882
UDI-DI
08680952301282
Basic UDI-DI
B-08680952301282
Reference
CESR 3
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
08.07.2026 12:28
Manufacturer productsView details
CP-3 Coagulation Control Plasma Level 3

CP-3 Coagulation Control Plasma Level 3

IVD generalIVDDOn the market
Manufacturer
Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.
Manufacturer SRN
TR-MF-000021882
UDI-DI
08680952301183
Basic UDI-DI
B-08680952301183
Reference
.
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
Türkiye
Authorised representative
-
Last updated
08.07.2026 12:28
Manufacturer productsView details
DIFCO

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IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use
Manufacturer
Becton, Dickinson and Company
Manufacturer SRN
US-MF-000018910
UDI-DI
00382902213413
Basic UDI-DI
038290KYXKQAGXPE
Reference
221341
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
-
Authorised representative
Becton Dickinson Ireland Limited
Last updated
07.07.2026 08:27
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
DIFCO

-

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use
Manufacturer
Becton, Dickinson and Company
Manufacturer SRN
US-MF-000018910
UDI-DI
00382902214212
Basic UDI-DI
038290KYXKQAGXPE
Reference
221421
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
-
Authorised representative
Becton Dickinson Ireland Limited
Last updated
07.07.2026 08:27
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06956013925073

Low-value: 6mL×1; Mid-value: 6mL×1; High-value: 6mL×1; Normal-value (negative): 6mL×1.

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
AVE Science & Technology Co., Ltd.
Manufacturer SRN
CN-MF-000031214
UDI-DI
06956013925073
Basic UDI-DI
B-06956013925073
Reference
--
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 21:35
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06956013923352

Negative Quality Control: 1mL×12 Sensitivity Quality Control: 1mL×12 Precision Quality Control: 1mL×12 Mixed package: 1mL×12. [Negative Quality Control: 1mL×4; Sensitivity Quality Control: 1mL×4; Precision Quality Control: 1mL×4.]

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent
Manufacturer
AVE Science & Technology Co., Ltd.
Manufacturer SRN
CN-MF-000031214
UDI-DI
06956013923352
Basic UDI-DI
B-06956013923352
Reference
--
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 21:35
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06956013922003

Negative Quality Control: 10mL×12; Positive Quality Control (Reconstitute Solution): 10mL×12; Positive Quality Control (Lyophilized Powder): 10mL×12; Mixed package: 10mL×12.

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
AVE Science & Technology Co., Ltd.
Manufacturer SRN
CN-MF-000031214
UDI-DI
06956013922003
Basic UDI-DI
B-06956013922003
Reference
--
EMDN
W01040699
EMDN description
CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER
First on market country
Germany
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
28.06.2026 21:35
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details