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259 device results listed.

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Kemilo IL-6 Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225932749
Basic UDI-DI: B-06971225932749
Reference: CC011M
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo IL-6 Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225932732
Basic UDI-DI: B-06971225932732
Reference: CC011L
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

Kemilo PCT Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225932596
Basic UDI-DI: B-06971225932596
Reference: CC005
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

AESQC® Pool 6

AESQC® Pool

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510189
Basic UDI-DI: B-04250289510189
Reference: AESQCP6
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

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AESQC® Pool 7

AESQC® Pool

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289510196
Basic UDI-DI: B-04250289510196
Reference: AESQCP7
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:39

Manufacturer products View details

03610522158263

AEA IgG POSITIVE CONTROL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 03610522158263
Basic UDI-DI: B-03610522158263
Reference: 12012273
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 05.07.2026 17:01

Manufacturer products View details

Contrôle Positif FOB

FOB positive Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670501633
Basic UDI-DI: B-03532670501633
Reference: 6110001
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

K-ASSAY ASO/RF/CRP Control

ASO/RF/CRP Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020856
Basic UDI-DI: B-00816426020856
Reference: K55C-4M
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Liquid ITA Control

Liquid ITA Control

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020825
Basic UDI-DI: B-00816426020825
Reference: K49C-4M
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

QUANTA Flash PR3 Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950554554
Basic UDI-DI: 84269505545548W
Reference: 701137
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 03.07.2026 13:06

Manufacturer products Authorised representative products Authorised representative actors View details

Evo Specific Control G4

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945154816
Basic UDI-DI: 8058945151PC2020G4EF
Reference: 1PC2020G4
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:14

Manufacturer products View details

Evo Specific Control G

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945154786
Basic UDI-DI: 8058945151PC2020GAM
Reference: 1PC2020G
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:14

Manufacturer products View details

Evo Specific Control E

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: ABD SRL
Manufacturer SRN: IT-MF-000029729
UDI-DI: 08058945154717
Basic UDI-DI: 8058945151PC20005X
Reference: 1PC2000
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 12:14

Manufacturer products View details

ImmunoCAP Specific IgE Negative Control

ImmunoCAP Specific IgE

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066019888
Basic UDI-DI: 7333066BUDI0004LN
Reference: 10-9445-01
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

ImmunoCAP Tryptase Control

ImmunoCAP Tryptase

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066019833
Basic UDI-DI: 7333066BUDI0063M6
Reference: 10-9370-01
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:18

Manufacturer products View details

ImmunoCAP Total IgE Control LMH

ImmunoCAP Total IgE

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066019642
Basic UDI-DI: 7333066BUDI0008LW
Reference: 10-9447-01
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:17

Manufacturer products View details

ImmunoCAP ECP Control

ImmunoCAP ECP

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066011288
Basic UDI-DI: 7333066BUDI0051LX
Reference: 10-9269-01
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

System Wash

350mL×1, 350mL×4, 5L×1, 10L×1

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: DiYaLab ZJG Biotech Co., Ltd
Manufacturer SRN: CN-MF-000048648
UDI-DI: 06975424228092
Basic UDI-DI: 697542422SystemWashZ2
Reference: 350mL×4
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

HA Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN EVER-BLUE BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000025048
UDI-DI: 06973880813029
Basic UDI-DI: 697388081022NS
Reference: ZCC039
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 15:09

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Cholylglycine (CLIA) Controls

Cholylglycine (CLIA) Controls

IVD Class BIVDR 2017/746On the marketProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145529369
Basic UDI-DI: 69471455466WR
Reference: 160201466MT
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
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