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EUDAMED Device Search

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

TREN

Last updated

22.09.2026 20:14

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Successful

Device

3539373

Actor

47770

Certificate

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Active filter:EMDN:W01050808

740 device results listed.

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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
70845357041431

8181

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041431
Basic UDI-DI
084535708181BB
Reference
[8181] QC Sets and Panels: Helix Elite™ Gram-Negative Blood Culture 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
70845357041424

8180

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041424
Basic UDI-DI
084535708180B9
Reference
[8180] QC Sets and Panels: Helix Elite™ Gram-Positive Blood Culture 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
70845357041400

8205

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041400
Basic UDI-DI
084535708205AY
Reference
[8205] QC Sets and Panels: Helix Elite™ Norovirus 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 05:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357041387

8203

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041387
Basic UDI-DI
084535708203AU
Reference
[8203] QC Sets and Panels: Helix Elite™ Vancomycin Resistant Enterococcus (VRE) 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 05:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357041363

8191

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041363
Basic UDI-DI
084535708191BE
Reference
[8191] QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification 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 05:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357041325

8209

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041325
Basic UDI-DI
084535708209B8
Reference
[8209] QC Sets and Panels: Helix Elite™ Vaginal 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 05:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357041318

8208

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041318
Basic UDI-DI
084535708208B6
Reference
[8208] QC Sets and Panels: Helix Elite™ Vaginal Verification Panel
EMDN
W0105080807
EMDN description
MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country
France
Authorised representative
MediMark Europe Sarl.
Last updated
16.07.2026 05:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357041202

8190

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041202
Basic UDI-DI
084535708190BC
Reference
[8190] QC Sets and Panels: Helix Elite™ Enterovirus (EV) 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 05:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357041196

8189

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041196
Basic UDI-DI
084535708189BT
Reference
[8189] QC Sets and Panels: Helix Elite™ Trichomonas vaginalis (TV) Control Panel (Inactivated Swab)
EMDN
W0105080807
EMDN description
MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country
France
Authorised representative
MediMark Europe Sarl.
Last updated
16.07.2026 05:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357041172

8187

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041172
Basic UDI-DI
084535708187BP
Reference
[8187] QC Sets and Panels: Helix Elite™ Carbapenem-resistant Enterobacteriaceae (CRE) 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 05:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357041158

8211

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041158
Basic UDI-DI
084535708211AT
Reference
[8211] QC Sets and Panels: Helix Elite™ Enteric Viral Control 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 05:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
70845357041141

8210

IVD Class BIVDR 2017/746On the marketMicrobial substancesProfessional testingSingle use
Manufacturer
Microbiologics, INC.
Manufacturer SRN
US-MF-000000466
UDI-DI
70845357041141
Basic UDI-DI
084535708210AR
Reference
[8210] QC Sets and Panels: Helix Elite™ Enteric Viral 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 05:55
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details