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EUDAMED Device Search

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

Last updated

23.09.2026 04:15

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Active filter:EMDN:W0105011101

53 device results listed.

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PATHODX STREP F GROUPING LATEX

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501277
Basic UDI-DI: 50560805PathoDXLatex3G
Reference: R62034
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX STREP G GROUPING LATEX

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501284
Basic UDI-DI: 50560805PathoDXLatex3G
Reference: R62035
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

PATHODX STREP GROUPING UNIVERSAL KIT

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501369
Basic UDI-DI: 50560805PathDXStrepC7
Reference: R62150
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501383
Basic UDI-DI: 50560805StreptexU9
Reference: R30164701
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX LATEX B

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501413
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30950701
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX LATEX C

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501420
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30950801
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX LATEX D

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501437
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30950901
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX LATEX F

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501444
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30951101
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

STREPTEX LATEX G

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IVD Class CNot specifiedOn the market

Manufacturer: Remel Europe Ltd
Manufacturer SRN: GB-MF-000016733
UDI-DI: 05056080501451
Basic UDI-DI: 50560805StreptexLatexRS
Reference: R30951201
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Netherlands
Authorised representative: Thermo Fisher Diagnostics B.V.
Last updated: 20.07.2026 11:27

Manufacturer products Authorised representative products Authorised representative actors View details

Streptococcus pneumoniae antigen rapid test

Streptococcus pneumoniae antigen rapid test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840312614
Basic UDI-DI: B-69743840312614
Reference: 3027401
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:13

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test Device (Swab)

Strep B Rapid Test Device (Swab)

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840309744
Basic UDI-DI: B-69743840309744
Reference: 3026201
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

mariPOC® Pneumococcus respiratory test reagent

mariPOC® Pneumococcus respiratory test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R11EG
Basic UDI-DI: B-1R11EG
Reference: 1R11
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:26

Manufacturer products View details

mariPOC® Group A streptococcus test reagent

mariPOC® Group A streptococcus test reagent

IVD generalIVDDOn the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: ArcDia International Oy Ltd
Manufacturer SRN: FI-MF-000007553
UDI-DI: D-1R02EF
Basic UDI-DI: B-1R02EF
Reference: 1R02
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Finland
Authorised representative: -
Last updated: 11.07.2026 14:17

Manufacturer products View details

Streptococcus Group B antisera

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genhawk (Wuhan) Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000042707
UDI-DI: 06977597620284
Basic UDI-DI: B-06977597620284
Reference: Streptococcus Group B antisera for quality contro（Type VIII）
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

Streptococcus Group B antisera

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Genhawk (Wuhan) Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000042707
UDI-DI: 06977597620109
Basic UDI-DI: B-06977597620109
Reference: Streptococcus Group B latex antisera (Type Ia)
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 07.07.2026 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

Group B Streptococcus Antigen Test Kit

Group B Streptococcus Antigen Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620568
Basic UDI-DI: B-06974854620568
Reference: P2200825
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

Group A Streptococcus Antigen Test Kit

Group A Streptococcus Antigen Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620551
Basic UDI-DI: B-06974854620551
Reference: P2200725
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:52

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test

Strep A Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302905
Basic UDI-DI: B-06974566302905
Reference: ISA-502
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Denmark
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test

Strep B Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566302899
Basic UDI-DI: B-06974566302899
Reference: ISB-502
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Austria
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Antigen Rapid Test

Strep A Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238911183
Basic UDI-DI: B-06974238911183
Reference: HSTR034GA
EMDN: W0105011101
EMDN description: STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 18:00

Manufacturer products Authorised representative products Authorised representative actors View details