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17 device results listed.

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Strep B Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISB-502SC
Basic UDI-DI: B-ISB-502SC
Reference: ISB-502
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test Dipstick

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISB-501SA
Basic UDI-DI: B-ISB-501SA
Reference: ISB-501
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.07.2026 18:09

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISB-R502FT
Basic UDI-DI: B-ISB-R502FT
Reference: ISB-R502
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:04

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646STB001PE67
Basic UDI-DI: B-697424646STB001PE67
Reference: STB-6011/STB-6012
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test Kit (swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646STB000PC5W
Basic UDI-DI: B-697424646STB000PC5W
Reference: STB-6011/STB-6012
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:15

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Antigen Rapid Test(Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ROT002RAAC
Basic UDI-DI: B-697424646ROT002RAAC
Reference: ROT-5011/ROT-5012
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Rapid Test (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646ROT000R69E
Basic UDI-DI: B-697424646ROT000R69E
Reference: ROT-5011/ROT-5012
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:14

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test (Swab)

ISB-1013

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750563
Basic UDI-DI: B-06974785750563
Reference: ISB-1013
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

NADAL® Strep B

Strep B

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-232001R3
Basic UDI-DI: B-nvm-232001R3
Reference: 232001
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:27

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Strep B Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-STB-K02aNQ
Basic UDI-DI: B-STB-K02aNQ
Reference: STB-K02a
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 10:45

Manufacturer products Authorised representative products Authorised representative actors View details

Group B Streptococcus Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD139XR
Basic UDI-DI: B-GKPD139XR
Reference: GKPD139
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Antigen Rapid Test Kit(Colloidal gold method)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Synthgene (Yixing) Health Technology Co., Ltd.
Manufacturer SRN: CN-MF-000054349
UDI-DI: D-CNMF000054349CR057b64
Basic UDI-DI: B-CNMF000054349CR057b64
Reference: CR057
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 13.07.2026 07:08

Manufacturer products Authorised representative products Authorised representative actors View details

INDICAID™Strep B Rapid Antigen Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A012CN
Basic UDI-DI: B-A012CN
Reference: INDICAID™Strep B Rapid Antigen Test
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 12.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698603669
Basic UDI-DI: B-16972698603669
Reference: P281003
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test

GISTB

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762258
Basic UDI-DI: B-06976202762258
Reference: GISTB-702
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test

STB-S23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827014
Basic UDI-DI: B-06952804827014
Reference: STB-S23
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep B Rapid Test

IVD generalNot specifiedOn the marketSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: 06937339209696
Basic UDI-DI: B-06937339209696
Reference: VISB-702
EMDN: W0105090104
EMDN description: STREP. B - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 22:56

Manufacturer products Authorised representative products Authorised representative actors View details