Veriler yükleniyor…

Public EUDAMED Search

EUDAMED Device Search

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

Last updated

01.08.2026 13:11

Sync status

Successful

Device

2989326

Actor

47520

Certificate

3174

Filters

Show filters

Active filter:EMDN:W0105080801

74 device results listed.

Page 3 / 4

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

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

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

Strep A Antigen Control Kit

GCSTR-PN2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCSTR-PN2Q4
Basic UDI-DI: B-GCSTR-PN2Q4
Reference: GCSTR-PN2
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Antigen Control Kit

GCSTR-PN2

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCSTR-PN2HGTH
Basic UDI-DI: B-GCSTR-PN2HGTH
Reference: GCSTR-PN2
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Ag Control Kit

GCHP-PN2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHP-PN2K6
Basic UDI-DI: B-GCHP-PN2K6
Reference: GCHP-PN2
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:28

Manufacturer products Authorised representative products Authorised representative actors View details

M. Pneumoniae IgM Control

M. Pneumoniae IgM Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC848RN
Basic UDI-DI: B-CC848RN
Reference: CC848
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

M. Pneumoniae IgG Control

M. Pneumoniae IgG Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC847RL
Basic UDI-DI: B-CC847RL
Reference: CC847
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

Procalcitonin Control

Procalcitonin Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC820QY
Basic UDI-DI: B-CC820QY
Reference: CC820
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-TP Control

Anti-TP Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: D-CC049QG
Basic UDI-DI: B-CC049QG
Reference: CC049
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 03:56

Manufacturer products Authorised representative products Authorised representative actors View details

CONTROL POSITIVO EN SECO CAMPYLOBACTER / CAMPYLOBACTER DRY POSITIVE CONTROL

9.230.XXX.12.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-8429577923012CR23
Basic UDI-DI: B-8429577923012CR23
Reference: 9.230.XXX.12.ZZZ
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

CONTROL POSITIVO STREP PNEUMO-LEGIO / STREP PNEUMO-LEGIO POSITIVE CONTROL

9.108.XXX.37.ZZZ

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-8429577910837DH3R
Basic UDI-DI: B-8429577910837DH3R
Reference: 9.108.XXX.37.ZZZ
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

ACCURUN 501 C. difficile Control

2050-0008

IVD generalIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020758
Basic UDI-DI: B-00816784020758
Reference: 2050-0008
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 700

2025-0068

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020697
Basic UDI-DI: B-00816784020697
Reference: 2025-0068
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 342 CT/NG Nucleic Acid Positive Control Series 100

2025-0067

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020680
Basic UDI-DI: B-00816784020680
Reference: 2025-0067
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details

ACCURUN 841 CT/NG Negative Control

2025-0061

IVD Annex II List BIVDDOn the marketHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: LGC Clinical Diagnostics, Inc.
Manufacturer SRN: US-MF-000016356
UDI-DI: 00816784020673
Basic UDI-DI: B-00816784020673
Reference: 2025-0061
EMDN: W0105080801
EMDN description: BACTERIOLOGY CONTROLS - INF.IMM.
First on market country: Ireland
Authorised representative: MediMark Europe Sarl.
Last updated: 04.07.2026 21:42

Manufacturer products Authorised representative products Authorised representative actors View details