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81 device results listed.

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Anti-TP Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC049QG
Basic UDI-DI: B-CC049QG
Reference: CC049
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

CONTROL POSITIVO EN SECO CAMPYLOBACTER / CAMPYLOBACTER DRY POSITIVE CONTROL

9.230.XXX.12.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-8429577923012CR23
Basic UDI-DI: B-8429577923012CR23
Reference: 9.230.XXX.12.ZZZ
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

CONTROL POSITIVO STREP PNEUMO-LEGIO / STREP PNEUMO-LEGIO POSITIVE CONTROL

9.108.XXX.37.ZZZ

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-8429577910837DH3R
Basic UDI-DI: B-8429577910837DH3R
Reference: 9.108.XXX.37.ZZZ
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

ACCURUN 501 C. difficile Control

2050-0008

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020758
Basic UDI-DI: B-00816784020758
Reference: 2050-0008
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700

2025-0068

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020697
Basic UDI-DI: B-00816784020697
Reference: 2025-0068
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100

2025-0067

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020680
Basic UDI-DI: B-00816784020680
Reference: 2025-0067
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 841 CT/NG Negative Control

2025-0061

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020673
Basic UDI-DI: B-00816784020673
Reference: 2025-0061
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000

2015-0093

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020475
Basic UDI-DI: B-00816784020475
Reference: 2015-0093
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:41

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 5000

2015-0092

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020468
Basic UDI-DI: B-00816784020468
Reference: 2015-0092
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:41

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 155 Anti-Treponema (Syphilis) Positive Control Series 2000

2015-0090

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020451
Basic UDI-DI: B-00816784020451
Reference: 2015-0090
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:41

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 130 Borrelia burgdorferi IgG Positive Control

2015-0080

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020376
Basic UDI-DI: B-00816784020376
Reference: 2015-0080
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:41

Manufacturer products Authorised representative products Authorised representative actors View details

CONTROL POSITIVO EN SECO GDH-TOXINS / DRY GDH-TOXINS POSITIVE CONTROL

9.065.XXX.12.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004808
Basic UDI-DI: 8429577906512DH
Reference: 9.065.011.12.000
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:18

Manufacturer products View details

CONTROL POSITIVO EN SECO H.PYL-TF || H.PYL-TF DRY POSITIVE CONTROL

9.231.XXX.12.ZZZ

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

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004051
Basic UDI-DI: 8429577923112CW
Reference: 9.231.011.12.000
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

MAGLUMI Legionella pneumophila IgM (CLIA) Controls

Legionella pneumophila IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547547
Basic UDI-DI: 69471455276WJ
Reference: 160201276MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Chlamydia pneumoniae IgM (CLIA) Controls

Chlamydia pneumoniae IgM (CLIA) Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145518721
Basic UDI-DI: 69471455192WB
Reference: 160201192MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Chlamydia pneumoniae IgG (CLIA) Controls

Chlamydia pneumoniae IgG (CLIA) Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145518714
Basic UDI-DI: 69471455191W9
Reference: 160201191MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Mycoplasma pneumoniae IgM (CLIA) Controls

Mycoplasma pneumoniae IgM (CLIA) Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145518707
Basic UDI-DI: 69471455190W7
Reference: 160201190MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Mycoplasma pneumoniae IgG (CLIA) Controls

Mycoplasma pneumoniae IgG (CLIA) Controls

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145518691
Basic UDI-DI: 69471455189WN
Reference: 160201189MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:52

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI H.pylori IgM (CLIA) Controls

H.pylori IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145523404
Basic UDI-DI: 694714551015HR
Reference: 1602011015MT
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:47

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Legionella pneumophila IgM (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547585
Basic UDI-DI: 69471455276WJ
Reference: 130219022M
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details