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19 device results listed.

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EV71 IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IEVM-402K5
Basic UDI-DI: B-IEVM-402K5
Reference: IEVM-402
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 20.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

EV71 IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Newlink Biotech co., Ltd.
Manufacturer SRN: CN-MF-000045176
UDI-DI: D-L11-EVM01C42S
Basic UDI-DI: B-L11-EVM01C42S
Reference: L11-EVM01C4
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 17.07.2026 05:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-A045D5

INDICAID™ Hand Foot And Mouth Disease Rapid Antibody Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A045D5
Basic UDI-DI: B-A045D5
Reference: INDICAID™ Hand Foot And Mouth Disease Rapid Antibody Test
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 17.07.2026 04:42

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EV71 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCEV71(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCEV71(IgM)-402a5W
Basic UDI-DI: B-GCEV71(IgM)-402a5W
Reference: GCEV71(IgM)-402a
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

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EV71 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

GCEV71(IgM)-402a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCEV71(IgM)-402aHGH9
Basic UDI-DI: B-GCEV71(IgM)-402aHGH9
Reference: GCEV71(IgM)-402a
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:26

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EV71 IgM Rapid Test Cassette (Serum/Plasma)

GCEV71(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCEV71(IgM)-302aHGGU
Basic UDI-DI: B-GCEV71(IgM)-302aHGGU
Reference: GCEV71(IgM)-302a
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

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EV71 IgM Rapid Test Cassette (Serum/Plasma)

GCEV71(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCEV71(IgM)-302a5P
Basic UDI-DI: B-GCEV71(IgM)-302a5P
Reference: GCEV71(IgM)-302a
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:25

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Enterovirus 71 Ag Test Device-Feces

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: D-D-FIEV71AGD25QH
Basic UDI-DI: B-D-FIEV71AGD25QH
Reference: D-FIEV71AGD25
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 14:15

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Enterovirus 71 Ag Test Device-Feces

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Rapid Labs Ltd
Manufacturer SRN: GB-MF-000026335
UDI-DI: D-D-FIEV71AGD10Q4
Basic UDI-DI: B-D-FIEV71AGD10Q4
Reference: D-FIEV71AGD10
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.07.2026 14:15

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RapidFor™ Enterovirus Ag Rapid Test Kit

VMD122

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030592
Basic UDI-DI: B-08684595030592
Reference: VMD122
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:14

Manufacturer products View details

RapidFor™ Enterovirus 71 IgM Rapid Test Kit

VMD108

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030479
Basic UDI-DI: B-08684595030479
Reference: VMD108
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:14

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Enterovirus Rapid Test

GIHEV

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763347
Basic UDI-DI: B-06976202763347
Reference: GIHEV-422
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

EV71 IgM Rapid Test

GIEV71

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763033
Basic UDI-DI: B-06976202763033
Reference: GIEV71-402
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:38

Manufacturer products Authorised representative products Authorised representative actors View details

Enterovirus 71 IgM Antibody Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620711
Basic UDI-DI: B-06974854620711
Reference: P2202120
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

Coxsackievirus A16 IgM Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303537
Basic UDI-DI: B-06974566303537
Reference: ICV-402
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Cyprus
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Enterovirus V71 IgM Rapid Test

25Tests/Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhuhai Encode Medical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000019361
UDI-DI: 06974566303445
Basic UDI-DI: B-06974566303445
Reference: IEV-402
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: France
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 19:56

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Coxsackievirus B IgM (CLIA)

Coxsackievirus B IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547806
Basic UDI-DI: 69471455279WQ
Reference: 130619021M
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 10:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Coxsackievirus B IgM (CLIA) Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547820
Basic UDI-DI: 69471455279WQ
Reference: 160201279MT
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Coxsackievirus B IgM (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145547837
Basic UDI-DI: 69471455279WQ
Reference: 130219021M
EMDN: W0105040602
EMDN description: ENTEROVIRUS
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 00:54

Manufacturer products Authorised representative products Authorised representative actors View details