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164 device results listed.

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Strep A Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ISTB-R502(ACRO)72
Basic UDI-DI: B-ISTB-R502(ACRO)72
Reference: ISTB-R502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Device

IST-502s

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Zhejiang QL Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000034990
UDI-DI: 06976081910016
Basic UDI-DI: 6976081918000000472W9
Reference: IST-502s
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Safety summary (SSCP/SSP): TF-12-25 · Rev. 2.4
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.08.2026 02:45

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Strep A Rapid Tests

ISAp001 ISAp002 ISAp008

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ISAp00LS
Basic UDI-DI: B-ISAp00LS
Reference: ISAp001 ISAp002 ISAp008
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 05.08.2026 15:32

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06970277510479
Basic UDI-DI: B-06970277510479
Reference: IST-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 23:46

Manufacturer products Authorised representative products Authorised representative actors View details

06941571834011

R34-112

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571834011
Basic UDI-DI: B-06941571834011
Reference: R34-112
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

06941571834004

R34-110

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Manufacturer SRN: CN-MF-000020607
UDI-DI: 06941571834004
Basic UDI-DI: B-06941571834004
Reference: R34-110
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 03.08.2026 14:54

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983188661
Basic UDI-DI: B-06936983188661
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

Cassette Test Rapide Strep A

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983164788
Basic UDI-DI: B-06936983164788
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:31

Manufacturer products Authorised representative products Authorised representative actors View details

06936983134613

Strep A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983134613
Basic UDI-DI: B-06936983134613
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Lithuania
Authorised representative: MedNet EC-REP GmbH
Last updated: 03.08.2026 14:30

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Strep A Test Card

1O08C5

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963711007
Basic UDI-DI: B-06921963711007
Reference: 1O08C5
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Greece
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:57

Manufacturer products Authorised representative products Authorised representative actors View details

TestPack Plus Strep A with OBC

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: Abbott Diagnostics Medical Co., Ltd.
Manufacturer SRN: JP-MF-000009543
UDI-DI: 04571226471784
Basic UDI-DI: B-04571226471784
Reference: 505715J
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: MDSS GmbH
Last updated: 02.08.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse

IVD Class BIVDR 2017/746On the marketDirect markingKitMicrobial substancesProfessional testingSingle use

Manufacturer: VitroBioChem SRL
Manufacturer SRN: RO-MF-000010877
UDI-DI: 05944759080096
Basic UDI-DI: 5944759080VTSTA25STSMB6Y7
Reference: VT-STA-25
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Romania
Authorised representative: -
Last updated: 31.07.2026 16:25

Manufacturer products View details

NADAL® Strep A Test

Strep A Test

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: 04065384000172
Basic UDI-DI: 4065384STA1OPS4N1GXEW
Reference: 20122N20
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 30.07.2026 23:21

Manufacturer products View details

D-IST-502(CT)Q4

Strep A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-IST-502(CT)Q4
Basic UDI-DI: B-IST-502(CT)Q4
Reference: IST-502(CT)
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 30.07.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISTB-R502GY
Basic UDI-DI: B-ISTB-R502GY
Reference: ISTB-R502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:44

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISTB-502N5
Basic UDI-DI: B-ISTB-502N5
Reference: ISTB-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:44

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISTB-501N3
Basic UDI-DI: B-ISTB-501N3
Reference: ISTB-501
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:44

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IST-R502P5
Basic UDI-DI: B-IST-R502P5
Reference: IST-R502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:44

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-STA-502X9
Basic UDI-DI: B-FI-STA-502X9
Reference: FI-STA-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 25.07.2026 01:42

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Device

Strip, Device

IVD Class BIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804804558
Basic UDI-DI: 69528048A463101ZT
Reference: A4631011
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.07.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details