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173 device results listed.

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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

Strep A Rapid Test 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: 06952804837174
Basic UDI-DI: 69528048A463101ZT
Reference: A4631021
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 22.07.2026 22:55

Manufacturer products Authorised representative products Authorised representative actors View details

D-697994388Ir0443GDF

Strep A Ag Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0443GDF
Basic UDI-DI: B-697994388Ir0443GDF
Reference: Ir044
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-697603130101A0202EYNC8E

101A0202EY

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Danwei Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000041344
UDI-DI: D-697603130101A0202EYNC8E
Basic UDI-DI: B-697603130101A0202EYNC8E
Reference: 101A0202EY
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:17

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test (Swab)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646STA001P74Y
Basic UDI-DI: B-697424646STA001P74Y
Reference: STA-6011/STA-6012
EMDN: W0105090103
EMDN description: STREP. A - 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 A 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-697424646STA000P54P
Basic UDI-DI: B-697424646STA000P54P
Reference: STA-6011/STA-6012
EMDN: W0105090103
EMDN description: STREP. A - 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

Strep A 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: 69743840307900
Basic UDI-DI: B-69743840307900
Reference: 3021104
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
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

LYSUN

STP-S21（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712009108W
Basic UDI-DI: B-69717712009108W
Reference: STP-S21（25PCS）
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details