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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Last updated

25.09.2026 13:12

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Device

3655407

Actor

47928

Certificate

3410

Active filter:Manufacturer SRN:US-MF-000000466

1000+ device results listed.

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80845357041650

0864E5

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
80845357041650
Basic UDI-DI
084535700864E5RM
Reference
[0864UE5] KWIK-STIK™ S. agalactiae ATCC 12401™
EMDN
W01040601
EMDN description
QC STRAINS BACTERIOLOGY
First on market country
France
Authorised representative
MediMark Europe Sarl.
Last updated
16.07.2026 05:56
Manufacturer productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
70845357043329

8243

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357043329
Basic UDI-DI
084535708243B8
Reference
[8243] Cdiff Verification Panel (Live Culture)
EMDN
W01040601
EMDN description
QC STRAINS BACTERIOLOGY
First on market country
France
Authorised representative
MediMark Europe Sarl.
Last updated
16.07.2026 05:56
Manufacturer productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
70845357041493

8219

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041493
Basic UDI-DI
084535708219BB
Reference
[8219] QC Sets and Panels: Helix Elite™ Group A Streptococcus (GAS) 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 productsAuthorised representative productsAuthorised representative actorsView details
70845357041448

8184

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041448
Basic UDI-DI
084535708184BH
Reference
[8184] QC Sets and Panels: Helix Elite™ Enteric Pathogens 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 productsAuthorised representative productsAuthorised representative actorsView details