- Manufacturer
- Vitrosens Biotechnology Inc.
- Manufacturer SRN
- TR-MF-000026452
- UDI-DI
- 08683548258465
- Basic UDI-DI
- B-08683548258465
- Reference
- LYO35
- EMDN
- W0105011105
- EMDN description
- STREP. PNEUMONIAE DETECTION BY NA REAGENTS
- First on market country
- Germany
- Authorised representative
- -
- Last updated
- 09.07.2026 00:19
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 16:25
Sync status
Successful
Device
2989422
Actor
47522
Certificate
3174
IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent
IVD generalIVDDOn the marketCompanion diagnosticsInstrumentKitNear-patient testingProfessional testingReagent
- Manufacturer
- Vitrosens Biotechnology Inc.
- Manufacturer SRN
- TR-MF-000026452
- UDI-DI
- 08683548257635
- Basic UDI-DI
- B-08683548257635
- Reference
- CFP62
- EMDN
- W0105011102
- EMDN description
- STREPTOCOCCAL DETECTION BY NA REAGENTS
- First on market country
- Germany
- Authorised representative
- -
- Last updated
- 09.07.2026 00:16
Xpert®
Xpert® GBS
IVD generalIVDDNo longer on the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Cepheid
- Manufacturer SRN
- US-MF-000010979
- UDI-DI
- D-07332940000127FC
- Basic UDI-DI
- B-07332940000127FC
- Reference
- GXGBS-100N-10
- EMDN
- W0105011104
- EMDN description
- STREP. B DETECTION BY NA REAGENTS
- First on market country
- Netherlands
- Authorised representative
- Cepheid AB
- Last updated
- 07.07.2026 04:14
Xpert®
Xpert® Xpress Strep A
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use
- Manufacturer
- Cepheid
- Manufacturer SRN
- US-MF-000010979
- UDI-DI
- 07332940006297
- Basic UDI-DI
- B-07332940006297
- Reference
- XPRSTREPA-CE-10
- EMDN
- W0105011103
- EMDN description
- STREP. A DETECTION BY NA REAGENTS
- First on market country
- Netherlands
- Authorised representative
- Cepheid AB
- Last updated
- 07.07.2026 04:06
06977597620291
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620291
- Basic UDI-DI
- B-06977597620291
- Reference
- Streptococcus Group B antisera for quality control(Type IX)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620284
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
06977597620277
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620277
- Basic UDI-DI
- B-06977597620277
- Reference
- Streptococcus Group B antisera for quality control(Type VII)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620260
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620260
- Basic UDI-DI
- B-06977597620260
- Reference
- Streptococcus Group B antisera for quality control(Type VI)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620253
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620253
- Basic UDI-DI
- B-06977597620253
- Reference
- Streptococcus Group B antisera for quality control(Type V)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620246
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620246
- Basic UDI-DI
- B-06977597620246
- Reference
- Streptococcus Group B antisera for quality control(Type IV)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620239
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620239
- Basic UDI-DI
- B-06977597620239
- Reference
- Streptococcus Group B antisera for quality control(Type III)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620222
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620222
- Basic UDI-DI
- B-06977597620222
- Reference
- Streptococcus Group B antisera for quality control(Type II)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620215
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620215
- Basic UDI-DI
- B-06977597620215
- Reference
- Streptococcus Group B antisera for quality control(Type Ib)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620208
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620208
- Basic UDI-DI
- B-06977597620208
- Reference
- Streptococcus Group B antisera for quality control (Type Ia)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620192
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620192
- Basic UDI-DI
- B-06977597620192
- Reference
- Streptococcus Group B latex antisera(Type IX)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620185
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620185
- Basic UDI-DI
- B-06977597620185
- Reference
- Streptococcus Group B latex antisera(Type VIII)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620178
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620178
- Basic UDI-DI
- B-06977597620178
- Reference
- Streptococcus Group B latex antisera(Type VII)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:26
06977597620161
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620161
- Basic UDI-DI
- B-06977597620161
- Reference
- Streptococcus Group B latex antisera(Type VI)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:24
06977597620154
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620154
- Basic UDI-DI
- B-06977597620154
- Reference
- Streptococcus Group B latex antisera(Type V)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:24
06977597620147
Streptococcus Group B antisera
IVD generalIVDDOn the marketProfessional testingReagentSingle use
- Manufacturer
- Genhawk (Wuhan) Biotech Co., Ltd.
- Manufacturer SRN
- CN-MF-000042707
- UDI-DI
- 06977597620147
- Basic UDI-DI
- B-06977597620147
- Reference
- Streptococcus Group B latex antisera(Type IV)
- EMDN
- W0105011199
- EMDN description
- STREPTOCOCCAL REAGENTS - OTHER
- First on market country
- Austria
- Authorised representative
- SUNGO Europe B.V.
- Last updated
- 07.07.2026 01:24