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702 device results listed.

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LIAISON® Control Anti-HAV

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

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100168
Basic UDI-DI: 80567713101713S
Reference: 310171
EMDN: W0105080802
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 12:07

Manufacturer products View details

MAGLUMI Dengue virus NS1 Antigen (CLIA) Controls

Dengue virus NS1 Antigen (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: 06947145565329
Basic UDI-DI: 69471455401VV
Reference: 160201401MT
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

NatQal HBV

NatQal HCV - HIV - HBV - HEV

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

Manufacturer: ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN: FR-MF-000013221
UDI-DI: 03760369292054
Basic UDI-DI: 376036929DGV0019K
Reference: 190015
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 08:04

Manufacturer products View details

NatQal B19-L

NatQal 2

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

Manufacturer: ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN: FR-MF-000013221
UDI-DI: 03760369291965
Basic UDI-DI: 376036929DGV0029M
Reference: 247901
EMDN: W0105080808
EMDN description: ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country: France
Authorised representative: -
Last updated: 16.07.2026 08:04

Manufacturer products View details

70845357044098

8254

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357044098
Basic UDI-DI: 084535708254BD
Reference: [8254] QC Sets and Panels: Helix Elite™ Blood Culture Identification Control Panel (43 Targets)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043749

8250

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043749
Basic UDI-DI: 084535708250B5
Reference: [8250] QC Sets and Panels: Helix Elite™ Candida vaginitis/Trichomonas vaginalis (CV/TV) Control Panel
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043602

8246

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043602
Basic UDI-DI: 084535708246BE
Reference: [8246] QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043732

8249

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043732
Basic UDI-DI: 084535708249BL
Reference: [8249] QC Sets and Panels: Helix Elite™ Bacterial Vaginosis (BV) Control Panel
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043619

8247

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043619
Basic UDI-DI: 084535708247BG
Reference: [8247] QC Sets and Panels: Helix Elite™ Respiratory Control Panel (22 Targets)
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043084

8235

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043084
Basic UDI-DI: 084535708235B9
Reference: [8235] QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Verification Panel
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043077

8234

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043077
Basic UDI-DI: 084535708234B7
Reference: [8234] QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357043060

8236

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357043060
Basic UDI-DI: 084535708236BB
Reference: [8236] QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042810

8206

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042810
Basic UDI-DI: 084535708206B2
Reference: [8206] QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042803

8238

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042803
Basic UDI-DI: 084535708238BF
Reference: [8238] QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Negative Control
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042735

8232

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042735
Basic UDI-DI: 084535708232B3
Reference: [8232] QC Sets and Panels: Helix Elite™ Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042728

8229

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042728
Basic UDI-DI: 084535708229BE
Reference: [8229] QC Sets and Panels: Helix Elite™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Control Panel
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042711

8227

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042711
Basic UDI-DI: 084535708227BA
Reference: [8227] QC Sets and Panels: Helix Elite™ C. difficile Control Panel (Inactivated Swab)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042704

8231

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042704
Basic UDI-DI: 084535708231AZ
Reference: [8231] QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042698

8230

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042698
Basic UDI-DI: 084535708230AX
Reference: [8230] QC Sets and Panels: Helix Elite™ Enteric Parasite Control Panel (Inactivated Pellet)
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details

70845357042681

8228

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 70845357042681
Basic UDI-DI: 084535708228BC
Reference: [8228] QC Sets and Panels: Helix Elite™ CT/GC/TV Control Panel (Inactivated Pellet)
EMDN: W0105080807
EMDN description: MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:56

Manufacturer products Authorised representative products Authorised representative actors View details