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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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07.07.2026 06:54

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106 device results listed.

Page 3 / 6

ICA2114-7

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

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564472
Basic UDI-DI: 697454156017LA
Reference: ICA2114-7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): BTK-CE17-0606 · Rev. A3
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:13

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

ICA2114-7

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

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564465
Basic UDI-DI: 697454156017LA
Reference: ICA2114-7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): BTK-CE17-0606 · Rev. A3
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:13

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

Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)

ICA2114-7

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

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564458
Basic UDI-DI: 697454156017LA
Reference: ICA2114-7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): BTK-CE17-0606 · Rev. A3
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:13

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

Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)

ICA2114-7

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

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564441
Basic UDI-DI: 697454156017LA
Reference: ICA2114-7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): BTK-CE17-0606 · Rev. A3
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:13

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

Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)

ICA2114-7

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

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564434
Basic UDI-DI: 697454156017LA
Reference: ICA2114-7
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Safety summary (SSCP/SSP): BTK-CE17-0606 · Rev. A3
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 12:13

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

-

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563253
Basic UDI-DI: 697454156001KT
Reference: SS001-2
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563260
Basic UDI-DI: 697454156001KT
Reference: SS001-3
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563277
Basic UDI-DI: 697454156001KT
Reference: SS001-4
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563284
Basic UDI-DI: 697454156001KT
Reference: SS001-5
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563291
Basic UDI-DI: 697454156001KT
Reference: SS001-6
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

-

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563307
Basic UDI-DI: 697454156001KT
Reference: SS001-7
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable sampling swab

-

Class IMDR 2017/745On the marketSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564731
Basic UDI-DI: 69745415618XU
Reference: ST001-2
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable sampling swab

-

Class IMDR 2017/745On the marketSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564748
Basic UDI-DI: 69745415618XU
Reference: ST001-3
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable sampling swab

-

Class IMDR 2017/745On the marketSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564755
Basic UDI-DI: 69745415618XU
Reference: ST001-4
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

Disposable sampling swab

-

Class IMDR 2017/745On the marketSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564762
Basic UDI-DI: 69745415618XU
Reference: ST001-5
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564779
Basic UDI-DI: 697454156008L9
Reference: ZK1000-1
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564786
Basic UDI-DI: 697454156008L9
Reference: ZK1500-1
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564793
Basic UDI-DI: 697454156008L9
Reference: ZK1000-5
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564809
Basic UDI-DI: 697454156008L9
Reference: ZK1500-3
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564816
Basic UDI-DI: 697454156008L9
Reference: ZK1500-4
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 16.06.2026 12:57

Manufacturer products Authorised representative products Authorised representative actors View details