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Last updated

22.09.2026 04:45

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3533322

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Active filter:EMDN:W01050111

241 device results listed.

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FlashDetect

FlashDetect™ Lyocart GBS Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Coyote Bioscience Co., Ltd.
Manufacturer SRN
CN-MF-000024155
UDI-DI
06974767392453
Basic UDI-DI
B-06974767392453
Reference
6018027102-CE
EMDN
W0105011104
EMDN description
STREP. B DETECTION BY NA REAGENTS
First on market country
Italy
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 20:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
FlashDetect

FlashDetect™ Lyocart Strep A Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Coyote Bioscience Co., Ltd.
Manufacturer SRN
CN-MF-000024155
UDI-DI
06974767392439
Basic UDI-DI
B-06974767392439
Reference
6018021905-CE
EMDN
W0105011103
EMDN description
STREP. A DETECTION BY NA REAGENTS
First on market country
Sweden
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 20:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
FlashDetect

FlashDetect™ Lyocart Strep A Assay

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
Coyote Bioscience Co., Ltd.
Manufacturer SRN
CN-MF-000024155
UDI-DI
06974767392422
Basic UDI-DI
B-06974767392422
Reference
6018021902-CE
EMDN
W0105011103
EMDN description
STREP. A DETECTION BY NA REAGENTS
First on market country
Sweden
Authorised representative
CMC Medical Devices & Drugs SL
Last updated
06.07.2026 20:42
Manufacturer productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
06974323012917

PCR-based Group B Streptococcus Test Kit (Fluorometric PCR)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN
CN-MF-000012338
UDI-DI
06974323012917
Basic UDI-DI
B-06974323012917
Reference
ID020
EMDN
W0105011104
EMDN description
STREP. B DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
Luxus Lebenswelt GmbH
Last updated
06.07.2026 18:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06974323012900

PCR-based Group B Streptococcus Test Kit (Fluorometric PCR)

IVD generalIVDDOn the marketProfessional testingReagentSingle use
Manufacturer
Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN
CN-MF-000012338
UDI-DI
06974323012900
Basic UDI-DI
B-06974323012900
Reference
ID020
EMDN
W0105011104
EMDN description
STREP. B DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
Luxus Lebenswelt GmbH
Last updated
06.07.2026 18:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView 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 productsAuthorised representative productsAuthorised representative actorsView details
StrongStep® Strep B Antigen Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN
CN-MF-000041298
UDI-DI
06973181850433
Basic UDI-DI
B-06973181850433
Reference
500090
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Northern Ireland
Authorised representative
Wellkang Ltd
Last updated
06.07.2026 16:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
StrongStep® Strep A Antigen Rapid Test

20 Tests/box

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
Manufacturer
Nanjing Liming Bio-products Co. Ltd
Manufacturer SRN
CN-MF-000041298
UDI-DI
06973181850396
Basic UDI-DI
B-06973181850396
Reference
500150
EMDN
W0105011101
EMDN description
STREPTOCOCCAL DIRECT ANTIGEN DETECTION
First on market country
Northern Ireland
Authorised representative
Wellkang Ltd
Last updated
06.07.2026 16:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
06972221450503

12 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use
Manufacturer
CapitalBio Technology (Chengdu) Co., Ltd.
Manufacturer SRN
CN-MF-000027694
UDI-DI
06972221450503
Basic UDI-DI
B-06972221450503
Reference
12 tests/kit
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
Netherlands
Authorised representative
SUNGO Europe B.V.
Last updated
06.07.2026 14:44
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Streptococcus Suis Real Time PCR Kit

Streptococcus Suis Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042228889
Basic UDI-DI
B-06971042228889
Reference
ZD-0069-02
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 12:02
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Group B Streptococcus (GBS)  Real Time PCR Kit

Group B Streptococcus (GBS)  Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042227752
Basic UDI-DI
B-06971042227752
Reference
RD-0237-02
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 11:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Group A Streptococcus (GAS) Real Time PCR Kit

Group A Streptococcus (GAS) Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042227714
Basic UDI-DI
B-06971042227714
Reference
RD-0180-02
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 11:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Streptococcus Pneumoniae Real Time PCR Kit

Streptococcus Pneumoniae Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042227707
Basic UDI-DI
B-06971042227707
Reference
RD-0146-02
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 11:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Streptococcus Pyogenes Real Time PCR Kit

Streptococcus Pyogenes Real Time PCR Kit

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
SHANGHAI ZJ BIO-TECH CO., LTD
Manufacturer SRN
CN-MF-000017861
UDI-DI
06971042227639
Basic UDI-DI
B-06971042227639
Reference
RD-0059-02
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA
Last updated
06.07.2026 11:59
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
MutaPLEX® GBS (Group B Streptococci), PCR

MutaPLEX® GBS (Group B Streptococci), PCR

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598003064
Basic UDI-DI
B-04050598003064
Reference
KG191032
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:42
Manufacturer productsView details
MutaPLEX® GBS (Group B Streptococci), PCR

MutaPLEX® GBS (Group B Streptococci), PCR

IVD generalIVDDOn the marketKitProfessional testingReagent
Manufacturer
Immundiagnostik AG
Manufacturer SRN
DE-MF-000020905
UDI-DI
04050598002272
Basic UDI-DI
B-04050598002272
Reference
KG191096
EMDN
W0105011102
EMDN description
STREPTOCOCCAL DETECTION BY NA REAGENTS
First on market country
Germany
Authorised representative
-
Last updated
06.07.2026 03:41
Manufacturer productsView details
Toda Strepdiag B 1

Toda Strepdiag B

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
TODA PHARMA
Manufacturer SRN
FR-MF-000007152
UDI-DI
03760309513249
Basic UDI-DI
B-03760309513249
Reference
1010-1
EMDN
W0105011104
EMDN description
STREP. B DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
-
Last updated
05.07.2026 21:59
Manufacturer productsView details
Toda Strepdiag B 10

Toda Strepdiag B 10

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use
Manufacturer
TODA PHARMA
Manufacturer SRN
FR-MF-000007152
UDI-DI
03760309513232
Basic UDI-DI
B-03760309513232
Reference
1010-10
EMDN
W0105011104
EMDN description
STREP. B DETECTION BY NA REAGENTS
First on market country
France
Authorised representative
-
Last updated
05.07.2026 21:59
Manufacturer productsView details