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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 21:38

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Device

3656173

Actor

47941

Certificate

3412

Active filter:Manufacturer SRN:US-MF-000000466

1000+ device results listed.

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70845357025653

5066P

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357025653
Basic UDI-DI
084535705066AM
Reference
[5066P] NH (4 Strains) QC Set
EMDN
W01040601
EMDN description
QC STRAINS BACTERIOLOGY
First on market country
France
Authorised representative
MediMark Europe Sarl.
Last updated
16.07.2026 05:54
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357025622

5065P

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357025622
Basic UDI-DI
084535705065AK
Reference
[5065P] ANA (3 Strains) QC Set
EMDN
W01040601
EMDN description
QC STRAINS BACTERIOLOGY
First on market country
France
Authorised representative
MediMark Europe Sarl.
Last updated
16.07.2026 05:54
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357025561

5062P

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357025561
Basic UDI-DI
084535705062AD
Reference
[5062P] Dried Overnight – Gram Negative Panel QC Set
EMDN
W01040601
EMDN description
QC STRAINS BACTERIOLOGY
First on market country
France
Authorised representative
MediMark Europe Sarl.
Last updated
16.07.2026 05:54
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357024878

5027P

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357024878
Basic UDI-DI
084535705027AB
Reference
[5027P] CLSI® M22 Chocolate Agar QC Set
EMDN
W01040601
EMDN description
QC STRAINS BACTERIOLOGY
First on market country
France
Authorised representative
MediMark Europe Sarl.
Last updated
16.07.2026 05:54
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357024663

5002P

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357024663
Basic UDI-DI
0845357050029T
Reference
[5002P] CLSI® MIC QC Set without Klebsiella pneumoniae
EMDN
W01040601
EMDN description
QC STRAINS BACTERIOLOGY
First on market country
France
Authorised representative
MediMark Europe Sarl.
Last updated
16.07.2026 05:54
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10845357043594

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357043570

HE0066NS

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
10845357043570
Basic UDI-DI
08453570HE0066NS32
Reference
[HE0066NS] Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Swab)
EMDN
W0105041106
EMDN description
CORONAVIRUS - NA REAGENTS
First on market country
France
Authorised representative
MediMark Europe Sarl.
Last updated
16.07.2026 05:53
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10845357043563

HE0065N

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
10845357043563
Basic UDI-DI
08453570HE0065NZF
Reference
[HE0065N] Helix Elite™ Molecular Standards Inactivated SARS-CoV-2 Whole Virus (Pellet)
EMDN
W0105041106
EMDN description
CORONAVIRUS - NA REAGENTS
First on market country
France
Authorised representative
MediMark Europe Sarl.
Last updated
16.07.2026 05:53
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10845357043273

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357043259

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357042795

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357042771

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357042672

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357042788

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357042191

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357042184

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357042177

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357042160

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357042153

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 productsAuthorised representative productsAuthorised representative actorsView details
10845357042146

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 productsAuthorised representative productsAuthorised representative actorsView details