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Active filter:EMDN:W01050808

832 device results listed.

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09343044002083

Synthetic Positive Controls for Atypical Pneumonia

IVD Annex II List BIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
AusDiagnostics Pty Ltd
Manufacturer SRN
AU-MF-000020558
UDI-DI
09343044002083
Basic UDI-DI
B-09343044002083
Reference
91071
EMDN
W0105080807
EMDN description
MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country
Italy
Authorised representative
R-Biopharm AG
Last updated
10.07.2026 23:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Synthetic Positive Controls for Bacteria and Bacterial Resistance

Synthetic Positive Controls for Bacteria and Bacterial Resistance

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
AusDiagnostics Pty Ltd
Manufacturer SRN
AU-MF-000020558
UDI-DI
09343044002045
Basic UDI-DI
B-09343044002045
Reference
91151
EMDN
W0105080807
EMDN description
MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country
Malta
Authorised representative
Advena Limited
Last updated
10.07.2026 23:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Synthetic Positive Controls for Fungal Panels

Synthetic Positive Controls for Fungal Panels

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
AusDiagnostics Pty Ltd
Manufacturer SRN
AU-MF-000020558
UDI-DI
09343044000508
Basic UDI-DI
B-09343044000508
Reference
91091
EMDN
W0105080807
EMDN description
MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country
Malta
Authorised representative
Advena Limited
Last updated
10.07.2026 23:41
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
COVID-19 Neutralization Ab Control LQ

COVID-19 Neutralization Ab Control LQ

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
NanoEntek, Inc.
Manufacturer SRN
KR-MF-000021903
UDI-DI
08809317541198
Basic UDI-DI
B-08809317541198
Reference
FIC-CONLQ
EMDN
W0105080804
EMDN description
OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country
Germany
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
10.07.2026 13:43
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
COVID-19 SP Control LQ

COVID-19 SP Control LQ

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
NanoEntek, Inc.
Manufacturer SRN
KR-MF-000021903
UDI-DI
08809317540948
Basic UDI-DI
B-08809317540948
Reference
FIC-COSLQ
EMDN
W0105080804
EMDN description
OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country
Germany
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
10.07.2026 13:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
COVID-19 IgG/IgM Control LQ

COVID-19 IgG/IgM Control LQ

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
NanoEntek, Inc.
Manufacturer SRN
KR-MF-000021903
UDI-DI
08809317540900
Basic UDI-DI
B-08809317540900
Reference
FIC-COLQ
EMDN
W0105080804
EMDN description
OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country
Germany
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
10.07.2026 13:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Influenza A&B control swab

Influenza A&B control swab

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
NanoEntek, Inc.
Manufacturer SRN
KR-MF-000021903
UDI-DI
08809317540726
Basic UDI-DI
B-08809317540726
Reference
FIC-FLSW
EMDN
W0105080804
EMDN description
OTHER VIROLOGY CONTROLS - INF.IMM.
First on market country
Germany
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
10.07.2026 13:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Atellica IM Toxoplasma IgM Quality Control (Toxo M QC)

-

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414600154
Basic UDI-DI
0405686901871W9
Reference
10995702
EMDN
W0105080805
EMDN description
PARASITOLOGY CONTROLS - INF.IMM.
First on market country
-
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
10.07.2026 06:46
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Atellica IM Toxoplasma IgG Quality Control (Toxo G QC)

-

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent
Manufacturer
Siemens Healthcare Diagnostics Inc.
Manufacturer SRN
US-MF-000016560
UDI-DI
00630414600130
Basic UDI-DI
0405686900835VW
Reference
10995700
EMDN
W0105080805
EMDN description
PARASITOLOGY CONTROLS - INF.IMM.
First on market country
-
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited
Last updated
09.07.2026 22:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
NatQal HAV

-

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use
Manufacturer
ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN
FR-MF-000013221
UDI-DI
03760369292030
Basic UDI-DI
376036929DGV0029M
Reference
247841
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
-
Authorised representative
-
Last updated
08.07.2026 22:50
Manufacturer productsView details
NatQal B19-L

-

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use
Manufacturer
ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN
FR-MF-000013221
UDI-DI
03760369291972
Basic UDI-DI
376036929DGV0029M
Reference
247900
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
-
Authorised representative
-
Last updated
08.07.2026 22:49
Manufacturer productsView details
NatQal B19-M

-

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use
Manufacturer
ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN
FR-MF-000013221
UDI-DI
03760369291996
Basic UDI-DI
376036929DGV0029M
Reference
247849
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
-
Authorised representative
-
Last updated
08.07.2026 22:49
Manufacturer productsView details
NatQal B19-M

-

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use
Manufacturer
ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN
FR-MF-000013221
UDI-DI
03760369292009
Basic UDI-DI
376036929DGV0029M
Reference
247848
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
-
Authorised representative
-
Last updated
08.07.2026 22:49
Manufacturer productsView details
NatQal HEV

-

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagentSingle use
Manufacturer
ETABLISSEMENT FRANCAIS DU SANG
Manufacturer SRN
FR-MF-000013221
UDI-DI
03760369292153
Basic UDI-DI
376036929DGV0019K
Reference
274283
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
-
Authorised representative
-
Last updated
08.07.2026 22:46
Manufacturer productsView details
myCROBE Universal Internal Control

myCROBE Universal Internal Control

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
GeneProof a.s.
Manufacturer SRN
CZ-MF-000002370
UDI-DI
08595696300067
Basic UDI-DI
B-08595696300067
Reference
UNIC/MC/180
EMDN
W0105080807
EMDN description
MULTICONSTITUENT CONTROLS - INF.IMM.
First on market country
Czechia
Authorised representative
-
Last updated
08.07.2026 01:57
Manufacturer productsView details
Polyvalent negative control, 1 x 1 mL

Polyvalent negative control, 1 x 1 mL

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use
Manufacturer
Chronolab Systems, S.L.
Manufacturer SRN
ES-MF-000017043
UDI-DI
D-084360385415413EF
Basic UDI-DI
B-084360385415413EF
Reference
101-0107
EMDN
W0105080899
EMDN description
CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country
Spain
Authorised representative
-
Last updated
08.07.2026 00:29
Manufacturer productsView details
Polyvalent positive control, 1 x 1 mL

Polyvalent positive control, 1 x 1 mL

IVD generalIVDDOn the marketAnimal tissuesKitReagentSingle use
Manufacturer
Chronolab Systems, S.L.
Manufacturer SRN
ES-MF-000017043
UDI-DI
D-084360385405406E7
Basic UDI-DI
B-084360385405406E7
Reference
101-0106
EMDN
W0105080899
EMDN description
CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country
Spain
Authorised representative
-
Last updated
08.07.2026 00:29
Manufacturer productsView details
Quality Control Kit for Logilet STl Panel

QC4021

IVD generalIVDDOn the marketKitReagentSingle use
Manufacturer
Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000031032
UDI-DI
06973315739382
Basic UDI-DI
B-06973315739382
Reference
QC4021
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
Spain
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 17:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Quality Control Kit for Logilet HPV Panel

QC4011

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use
Manufacturer
Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN
CN-MF-000031032
UDI-DI
06973315739306
Basic UDI-DI
B-06973315739306
Reference
QC4011
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
Spain
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 17:03
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Control Set for rapid SARS-CoV-2 PCR

Control set for rapid SARS-CoV-2 PCR

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent
Manufacturer
BIOSYNEX
Manufacturer SRN
FR-MF-000014073
UDI-DI
03532670503736
Basic UDI-DI
B-03532670503736
Reference
6150006
EMDN
W0105080808
EMDN description
ALL INFECTIOUS DISEASES CONTROLS - NAT
First on market country
France
Authorised representative
-
Last updated
05.07.2026 16:38
Manufacturer productsView details