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153 device results listed.

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TROD'ANGINE+

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 03770011742691
Basic UDI-DI: B-03770011742691
Reference: TR-ANG-009
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:22

Manufacturer products View details

TROD'ANGINE

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: AAZ PRODUCTIONS LE MATERIEL BIOMEDICAL
Manufacturer SRN: FR-MF-000015889
UDI-DI: 03770011742172
Basic UDI-DI: B-03770011742172
Reference: TR-ANG-008
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 22:22

Manufacturer products View details

BIOSYNEX Strep A

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03700531700277
Basic UDI-DI: B-03700531700277
Reference: 1030005
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 19:24

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX Strep A BSX

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX Swiss SA
Manufacturer SRN: CH-MF-000024717
UDI-DI: 03532670100874
Basic UDI-DI: B-03532670100874
Reference: 1030005_BSX
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: BIOSYNEX
Last updated: 05.07.2026 16:37

Manufacturer products Authorised representative products Authorised representative actors View details

Group A streptococcus Rapid test Kit

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Jiangsu Medomics Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000030226
UDI-DI: D-012124L3
Basic UDI-DI: B-012124L3
Reference: 012124-20-111
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Finland
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 05.07.2026 16:09

Manufacturer products Authorised representative products Authorised representative actors View details

VIRAPID® STREPTOCOCCUS GROUP A Ag

VRC003

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436610290869
Basic UDI-DI: 843661029VRC00301PU
Reference: VRC003
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 14:58

Manufacturer products View details

Simple / Stick Strep A

9.134.XXX.YY.ZZZ

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: 08429577004143
Basic UDI-DI: 84295779134XX
Reference: 9.134.040.00.000
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 03.07.2026 13:17

Manufacturer products View details

GenSure Strep A Rapid Test

Strep A Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSelf testingSingle use

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230364
Basic UDI-DI: 697683823P201900F9
Reference: P2019C01
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Cyprus
Safety summary (SSCP/SSP): GS/TD-EU-P2019-901 · Rev. A/2
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 22:10

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

Strep A Rapid Test

GISTA-702H

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202760032
Basic UDI-DI: 697620276GISTA000014E
Reference: GISTA-702H(2T/kit)
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Poland
Safety summary (SSCP/SSP): TD020-SSP · Rev. 05
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:18

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

Strep A Rapid Test

GISTA-702H

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202760025
Basic UDI-DI: 697620276GISTA000014E
Reference: GISTA-702H(1T/kit)
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Poland
Safety summary (SSCP/SSP): TD020-SSP · Rev. 05
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:18

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

Strep A Rapid Test

GISTA-702H

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202760018
Basic UDI-DI: 697620276GISTA000014E
Reference: GISTA-702H(5T/kit)
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Poland
Safety summary (SSCP/SSP): TD020-SSP · Rev. 05
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:18

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

Strep A Rapid Test

GISTA-702H

IVD Class CIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202760001
Basic UDI-DI: 697620276GISTA000014E
Reference: GISTA-702H(25T/kit)
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Poland
Safety summary (SSCP/SSP): TD020-SSP · Rev. 05
Authorised representative: Lotus NL B.V.
Last updated: 30.06.2026 12:18

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

06970895474252

Strep A Antigen Test Kit

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895474252
Basic UDI-DI: B-06970895474252
Reference: R226T020B0C0
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Greece
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 09:55

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® Strep A Cassette (Throat Swab)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430258
Basic UDI-DI: B-06970581430258
Reference: ABT-IDT-B15
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details

06970277510493

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: 06970277510493
Basic UDI-DI: B-06970277510493
Reference: IST-502
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 30.06.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test

STA-S23

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804827007
Basic UDI-DI: B-06952804827007
Reference: STA-S23
EMDN: W0105090103
EMDN description: STREP. A - 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

06952804825638

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: 06952804825638
Basic UDI-DI: 69528048A463101ZT
Reference: A4631011, A46310120, A46310140, A4631021, A46310220, A46310240; A46300120, A46300140, A46300220, A46300240
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Malta
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:32

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: 06952804809720
Basic UDI-DI: 69528048A463101ZT
Reference: A46310120
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

STA FIA

STA-S23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804802899
Basic UDI-DI: B-06952804802899
Reference: STA-S23F3
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:23

Manufacturer products Authorised representative products Authorised representative actors View details

Strep A Rapid Test Cassette (Throat Swab)

GCSTR-502a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: 06950996053938
Basic UDI-DI: B-06950996053938
Reference: GCSTR-502a
EMDN: W0105090103
EMDN description: STREP. A - RT & POC
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 09:34

Manufacturer products Authorised representative products Authorised representative actors View details