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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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23.09.2026 08:13

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740 device results listed.

Page 13 / 37

HE0067NS

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043594
Basic UDI-DI: 08453570HE0067NS37
Reference: [HE0067NS] Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Swab)
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0058N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043273
Basic UDI-DI: 08453570HE0058NZK
Reference: [HE0058N] Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Pellet)
EMDN: W0105080899
EMDN description: CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0056N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357043259
Basic UDI-DI: 08453570HE0056NZD
Reference: [HE0056N] Helix Elite™ Molecular Standards Human Papillomavirus 16 (HPV 16) Cellularity Control (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 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0055NS

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042795
Basic UDI-DI: 08453570HE0055NS2N
Reference: [HE0055NS] Helix Elite™ Molecular Standards Methicillin-Susceptible Staphylococcus epidermidis (MSSE)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0053NS

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042771
Basic UDI-DI: 08453570HE0053NS2C
Reference: [HE0053NS] Helix Elite™ Molecular Standards Methicillin-Resistant Staphylococcus aureus (MRSA) 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 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0052N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042672
Basic UDI-DI: 08453570HE0052NYZ
Reference: [HE0052N] Helix Elite™ Molecular Standards Inactivated Borrelia burgdorferi
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0054NS

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042788
Basic UDI-DI: 08453570HE0054NS2H
Reference: [HE0054NS] Helix Elite™ Molecular Standards Methicillin-Susceptible Staphylococcus aureus (MSSA) 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 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0045N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042191
Basic UDI-DI: 08453570HE0045NZ5
Reference: [HE0045N] Helix Elite™ Molecular Standards Inactivated Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/NG)
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0044N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042184
Basic UDI-DI: 08453570HE0044NZ2
Reference: [HE0044N] Helix Elite™ Molecular Standards Inactivated Influenza A/B and Respiratory Syncytial Virus
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0043N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042177
Basic UDI-DI: 08453570HE0043NYX
Reference: [HE0043N] Helix Elite™ Molecular Standards Inactivated Influenza A (H3N2) Virus
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0042N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042160
Basic UDI-DI: 08453570HE0042NYU
Reference: [HE0042N] Helix Elite™ Molecular Standards Inactivated Trichomonas vaginalis Strain GL0028
EMDN: W0105080805
EMDN description: PARASITOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0041N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042153
Basic UDI-DI: 08453570HE0041NYR
Reference: [HE0041N] Helix Elite™ Molecular Standards Inactivated Neisseria gonorrhoeae Strain GL0071
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0040N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042146
Basic UDI-DI: 08453570HE0040NYN
Reference: [HE0040N] Helix Elite™ Molecular Standards Inactivated Cytomegalovirus High Control Strain AD-169
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0037N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042115
Basic UDI-DI: 08453570HE0037NZ6
Reference: [HE0037N] Helix Elite™ Molecular Standards Inactivated Herpes Simplex Virus 2 Strain MS
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0036N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042108
Basic UDI-DI: 08453570HE0036NZ3
Reference: [HE0036N] Helix Elite™ Molecular Standards Inactivated Herpes Simplex Virus 1 Strain MacIntyre
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0035N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042092
Basic UDI-DI: 08453570HE0035NYY
Reference: [HE0035N] Helix Elite™ Molecular Standards Inactivated Chlamydia trachomatis Strain LGV-2-434
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0034N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042085
Basic UDI-DI: 08453570HE0034NYV
Reference: [HE0034N] Helix Elite™ Molecular Standards Inactivated Chlamydia pneumoniae CWL-029
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0033N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042078
Basic UDI-DI: 08453570HE0033NYS
Reference: [HE0033N] Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 3 Strain C243
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0032N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042061
Basic UDI-DI: 08453570HE0032NYP
Reference: [HE0032N] Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 2 Strain Greer
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details

HE0031N

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

Manufacturer: Microbiologics, INC.
Manufacturer SRN: US-MF-000000466
UDI-DI: 10845357042054
Basic UDI-DI: 08453570HE0031NYL
Reference: [HE0031N] Helix Elite™ Molecular Standards Inactivated Parainfluenza Virus 1 Strain VP1
EMDN: W0105080804
EMDN description: OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 05:53

Manufacturer products Authorised representative products Authorised representative actors View details