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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

21.09.2026 20:20

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Device

3158146

Actor

47652

Certificate

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Active filter:EMDN:W0105011101

53 device results listed.

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10743816000891

BioStrep A

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use
Manufacturer
Princeton BioMeditech Corporation
Manufacturer SRN
US-MF-000048310
UDI-DI
10743816000891
Basic UDI-DI
B-10743816000891
Reference
BSP-185-30
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
-
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
04.08.2026 17:49
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
10743816000839

Status Strep A

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use
Manufacturer
Princeton BioMeditech Corporation
Manufacturer SRN
US-MF-000048310
UDI-DI
10743816000839
Basic UDI-DI
B-10743816000839
Reference
34130
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
-
Authorised representative
Medical Technology Promedt Consulting GmbH
Last updated
04.08.2026 17:49
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
DyonStrepA-strip

DyonStrepA-strip

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
DYONMED SA
Manufacturer SRN
GR-MF-000033588
UDI-DI
05200251200319
Basic UDI-DI
B-05200251200319
Reference
DNWA104
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Greece
Authorised representative
-
Last updated
02.08.2026 18:47
Manufacturer productsView details
STREPTOCOCCAL GROUPING KIT

STREPTOCOCCAL GROUPING KIT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Oxoid Ltd
Manufacturer SRN
GB-MF-000016914
UDI-DI
05032384013036
Basic UDI-DI
5032384StrepGroupingKitQQ
Reference
DR0585A
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Netherlands
Authorised representative
Thermo Fisher Diagnostics B.V.
Last updated
31.07.2026 13:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
STREPTOCOCCAL GROUPING REAGENT A

OXOID STREPTOCOCCAL GROUPING REAGENTS

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Oxoid Ltd
Manufacturer SRN
GB-MF-000016914
UDI-DI
05032384013043
Basic UDI-DI
5032384StrepGroupLatexPP
Reference
DR0586G
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Netherlands
Authorised representative
Thermo Fisher Diagnostics B.V.
Last updated
31.07.2026 13:07
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PATHODXTRA STREP GROUPING KIT

PATHODXTRA STREP GROUPING KIT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Oxoid Ltd
Manufacturer SRN
GB-MF-000016914
UDI-DI
05032384519552
Basic UDI-DI
5032384PathoDxtraStrepZC
Reference
DR0700M
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Netherlands
Authorised representative
Thermo Fisher Diagnostics B.V.
Last updated
31.07.2026 13:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PATHODXTRA STREP GROUP A LATEX

PATHODXTRA STREP GROUP LATEX

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Oxoid Ltd
Manufacturer SRN
GB-MF-000016914
UDI-DI
05032384519835
Basic UDI-DI
5032384PathoDxtraLatexTL
Reference
DR0701G
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Netherlands
Authorised representative
Thermo Fisher Diagnostics B.V.
Last updated
31.07.2026 13:06
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
STREPTEX LATEX A

STREPTEX LATEX

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Remel Europe Ltd
Manufacturer SRN
GB-MF-000016733
UDI-DI
05056080501406
Basic UDI-DI
50560805StreptexLatexRS
Reference
R30950601
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Netherlands
Authorised representative
Thermo Fisher Diagnostics B.V.
Last updated
31.07.2026 08:23
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
STREPTEX RAPID

STREPTEX RAPID

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Remel Europe Ltd
Manufacturer SRN
GB-MF-000016733
UDI-DI
05056080501390
Basic UDI-DI
50560805StreptexAcidL5
Reference
R30950555
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Netherlands
Authorised representative
Thermo Fisher Diagnostics B.V.
Last updated
31.07.2026 08:23
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
STREPTEX

STREPTEX

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Remel Europe Ltd
Manufacturer SRN
GB-MF-000016733
UDI-DI
05056080501376
Basic UDI-DI
50560805StreptexU9
Reference
R30950501
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Netherlands
Authorised representative
Thermo Fisher Diagnostics B.V.
Last updated
31.07.2026 08:23
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PATHODX STREP GROUPING UNIVERSAL KIT

PATHODX STREP GROUPING UNIVERSAL KIT

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent
Manufacturer
Remel Europe Ltd
Manufacturer SRN
GB-MF-000016733
UDI-DI
05056080501352
Basic UDI-DI
50560805PathDXStrepC7
Reference
R62076
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Netherlands
Authorised representative
Thermo Fisher Diagnostics B.V.
Last updated
31.07.2026 08:23
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PATHODX STREP A GROUPING LATEX

PATHODX STREP GROUPING LATEX

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent
Manufacturer
Remel Europe Ltd
Manufacturer SRN
GB-MF-000016733
UDI-DI
05056080501246
Basic UDI-DI
50560805PathoDXLatex3G
Reference
R62030
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Netherlands
Authorised representative
Thermo Fisher Diagnostics B.V.
Last updated
31.07.2026 08:22
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
PATHODX STREP GROUPING KIT

PATHODX STREP GROUPING KIT

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
Manufacturer
Remel Europe Ltd
Manufacturer SRN
GB-MF-000016733
UDI-DI
05056080501239
Basic UDI-DI
50560805PathoDXStrep98
Reference
R62025
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Netherlands
Authorised representative
Thermo Fisher Diagnostics B.V.
Last updated
31.07.2026 08:22
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details