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23.09.2026 04:15

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337 device results listed.

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HemosIL AcuStar Multi-Ab Controls

00009800003

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950584926
Basic UDI-DI: 8426950584926AE
Reference: 00009800003
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:11

Manufacturer products Authorised representative products Authorised representative actors View details

MeMed BV® External Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: MeMed Diagnostics Ltd.
Manufacturer SRN: IL-MF-000023622
UDI-DI: 17290018739034
Basic UDI-DI: 729001873903CY
Reference: FG12001
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 03.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid Multi Control

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED
Manufacturer SRN: CN-MF-000042193
UDI-DI: 06977290930499
Basic UDI-DI: 697729093IC0491GB
Reference: IC04910-020
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 22:24

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatic Fibrosis Related Marker Multi Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880815207
Basic UDI-DI: 697388081059PH
Reference: ZCC049
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:10

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224556

Check-P

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224556
Basic UDI-DI: 6973262860006525
Reference: 01.09.31.01.Q.32
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Thyroid Function Multi Control

105-007383-00、 105-007379-00、105-007371-00、105-007375-00、105-007384-00、105-007380-00、105-007372-00、105-007376-00

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415921835
Basic UDI-DI: 69449040004L-TFM-Con***V9
Reference: 105-007375-00
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Hypertension Multi Control

105-012437-00、105-012438-00、105-012439-00、105-012440-00

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415919016
Basic UDI-DI: 69449040004U-HTN-Con***7J
Reference: 105-012437-00
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Reproductive Multi Control

105-004266-00、105-004272-00、105-008888-00、 105-008890-00、105-004267-00、105-004273-00、105-008889-00、105-008891-00

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415908034
Basic UDI-DI: 69449040004H-RM-Con****NJ
Reference: 105-008890-00
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

Liver Fibrosis Multi Control

105-010229-00、105-010249-00、105-010239-00、105-010259-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900724
Basic UDI-DI: 69449040004S-LFM-Con***W4
Reference: 105-010249-00
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802613689

Tumor Marker Controls

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

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802613689
Basic UDI-DI: 69268026MD773M000000001CS
Reference: MCL14801E
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802606940

Inflammatory Marker Controls

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

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802606940
Basic UDI-DI: 69268026MD773K000000001AY
Reference: MCL08801E
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802606919

Cardiac Marker Controls

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

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802606919
Basic UDI-DI: 69268026MD773J000000001A3
Reference: MCL08401E
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

06926802606643

Sexual Hormone Controls

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

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802606643
Basic UDI-DI: 69268026MD773A000000001ZT
Reference: MCL07501E
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 02.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors View details

IMMUNOLOGY CONTROL 1

IMMUNOLOGY CONTROL

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Medicon Hellas SA
Manufacturer SRN: GR-MF-000013625
UDI-DI: 05204309111299
Basic UDI-DI: 5204309000050NR
Reference: 1578-1195-04
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Greece
Authorised representative: -
Last updated: 02.07.2026 02:53

Manufacturer products View details

Access MeMed BV QC (Kit)

D05593

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590787127
Basic UDI-DI: 150995901AccMeMedBVQCZ4
Reference: D05593
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:40

Manufacturer products Authorised representative products Authorised representative actors View details

Endocrine Control

Analyzer (automatic and non-automatic)

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050591
Basic UDI-DI: 697492505000004TA
Reference: BYZKE0301
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Endocrine Control

Analyzer (automatic and non-automatic)

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050577
Basic UDI-DI: 697492505000004TA
Reference: BYZKE0201
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Endocrine Control

Analyzer (automatic and non-automatic)

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050553
Basic UDI-DI: 697492505000004TA
Reference: BYZKE0101
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Inflammation Markers Control

Analyzer (automatic and non-automatic)

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050218
Basic UDI-DI: 697492505000002T6
Reference: BYZKB0301
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details

Inflammation Markers Control

Analyzer (automatic and non-automatic)

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zhengzhou Bioyuan Biotech Co. Ltd.
Manufacturer SRN: CN-MF-000021426
UDI-DI: 06974925050171
Basic UDI-DI: 697492505000002T6
Reference: BYZKB0201
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 12:14

Manufacturer products Authorised representative products Authorised representative actors View details