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312 device results listed.

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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

MAGLUMI PIIIP N-P (CLIA) Controls

PIIIP N-P (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: 06947145529321
Basic UDI-DI: 69471455465WP
Reference: 160201465MT
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

MAGLUMI Hyaluronic Acid (CLIA) Controls

Hyaluronic Acid (CLIA) Controls

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145529284
Basic UDI-DI: 69471455464WM
Reference: 160201464MT
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

MAGLUMI PCT (CLIA) Controls

PCT (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: 06947145520748
Basic UDI-DI: 69471455471WJ
Reference: 160201471MT
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

MAGLUMI Col IV (CLIA) Controls

Col IV (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: 06947145520625
Basic UDI-DI: 69471455463WK
Reference: 160201463MT
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

MAGLUMI Laminin (CLIA) Controls

Laminin (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: 06947145520588
Basic UDI-DI: 69471455462WH
Reference: 160201462MT
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

MAGLUMI Tissue plasminogen activator-Plasminogen activator inhibitor Complex (CLIA) Controls

Tissue plasminogen activator-Plasminogen activator inhibitor Complex (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: 06947145518769
Basic UDI-DI: 69471455237W8
Reference: 160201237MT
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

MAGLUMI α2-Plasmininhibitor-Plasmin Complex (CLIA) Controls

α2-Plasmininhibitor-Plasmin Complex (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: 06947145518752
Basic UDI-DI: 69471455236W6
Reference: 160201236MT
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