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EUDAMED Device Search

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

Last updated

25.09.2026 10:26

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Active filter:EMDN:W01050808

832 device results listed.

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D-697603130CMTBMDRZK01639

CMTBMDRZK01-AHG4E

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000041344
UDI-DI
D-697603130CMTBMDRZK01639
Basic UDI-DI
B-697603130CMTBMDRZK01639
Reference
CMTBMDRZK01-AHG4E
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
17.07.2026 04:18
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000041344
UDI-DI
D-697603130CGBSZK01ACKM6
Basic UDI-DI
B-697603130CGBSZK01ACKM6
Reference
CGBSZK01A-AHG4E
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
17.07.2026 04:18
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN
CN-MF-000041344
UDI-DI
D-697603130CDGVZK01YJ4Z
Basic UDI-DI
B-697603130CDGVZK01YJ4Z
Reference
CDGVZK01-AHG4E
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
17.07.2026 04:18
IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN
CN-MF-000017965
UDI-DI
D-69509960AMTBZK01DJEZ
Basic UDI-DI
B-69509960AMTBZK01DJEZ
Reference
AMTBZK01-AHG2E
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
Germany
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
17.07.2026 03:52
LIAISON® Control Mycoplasma pneumoniae IgG

LIAISON® Control Mycoplasma pneumoniae IgG

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
Manufacturer
DiaSorin Italia S.p.A.
Manufacturer SRN
IT-MF-000029422
UDI-DI
08056771101196
Basic UDI-DI
B-08056771101196
Reference
317021
EMDN
W0105080801
EMDN description
BACTERIOLOGY CONTROLS - INF.IMM.
First on market country
Italy
Authorised representative
-
Last updated
16.07.2026 22:31
LIAISON® Control Anti-HAV

LIAISON® Control Anti-HAV

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent
Manufacturer
DiaSorin Italia S.p.A.
Manufacturer SRN
IT-MF-000029422
UDI-DI
08056771100168
Basic UDI-DI
80567713101713S
Reference
310171
EMDN
W0105080802
EMDN description
HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country
Italy
Authorised representative
-
Last updated
16.07.2026 12:07
MAGLUMI Dengue virus NS1 Antigen (CLIA) Controls

Dengue virus NS1 Antigen (CLIA) Controls

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testing
Manufacturer
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN
CN-MF-000005655
UDI-DI
06947145565329
Basic UDI-DI
69471455401VV
Reference
160201401MT
EMDN
W0105080804
EMDN description
OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country
Italy
Authorised representative
Shanghai International Holding Corp. GmbH(Europe)
Last updated
16.07.2026 10:42
NatQal HBV

NatQal HCV - HIV - HBV - HEV

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use
Manufacturer
ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN
FR-MF-000013221
UDI-DI
03760369292054
Basic UDI-DI
376036929DGV0019K
Reference
190015
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
France
Authorised representative
-
Last updated
16.07.2026 08:04
NatQal B19-L

NatQal 2

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use
Manufacturer
ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN
FR-MF-000013221
UDI-DI
03760369291965
Basic UDI-DI
376036929DGV0029M
Reference
247901
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
France
Authorised representative
-
Last updated
16.07.2026 08:04
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
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
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
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
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
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
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
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
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
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
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