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

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106 device results listed.

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06974541565424

2 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565424
Basic UDI-DI: B-06974541565424
Reference: ICA2229
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Poland
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565417

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565417
Basic UDI-DI: B-06974541565417
Reference: ICA2229
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Denmark
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565400

20 tests/kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565400
Basic UDI-DI: B-06974541565400
Reference: ICA2225
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565394

5 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565394
Basic UDI-DI: B-06974541565394
Reference: ICA2225
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Hungary
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565387

2 tests/kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565387
Basic UDI-DI: B-06974541565387
Reference: ICA2225
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Croatia
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565370

1 test/kit

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565370
Basic UDI-DI: B-06974541565370
Reference: ICA2225
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Austria
Authorised representative: Medunion S.L.
Last updated: 06.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565363

ST6001

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565363
Basic UDI-DI: 697454156016L8
Reference: ST6001
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565264

BTK-8-B10-10-00, BTK-8-B8-10-00, BTK-8-B4-10-00, BTK-8-B4-20-00, BTK-E04-B1-20-00, BTK-E04-B1-25-00, BTK-E04-B1-30-00, BTK-E04-B1-40-00, BTK-E02-B48-20-00, BTK-E02-B48-25-00"

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565264
Basic UDI-DI: 697454156014L4
Reference: BTK-8-B10-10-00
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565233

AU1001-2,AU1001-3,AU1001-5

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565233
Basic UDI-DI: 697454156015L6
Reference: AU1001-2
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565226

BF4096

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565226
Basic UDI-DI: 697454156009LB
Reference: BF4096
EMDN: W02060102
EMDN description: AUTOMATED SAMPLE TRANSPORT SYSTEMS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565202

BTK-8, BTK-1

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565202
Basic UDI-DI: 697454156006L5
Reference: BTK-8
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565097

PT10, PT50, PT100, PT200, PT1000, PT5000, PTE10, PTE50, PTE100, PTE200, PTE300

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565097
Basic UDI-DI: 697454156011KW
Reference: PT10
EMDN: W0503020199
EMDN description: PIPETTES - OTHER
First on market country: Bulgaria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565066

ZK1000,ZK1500

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565066
Basic UDI-DI: 697454156007L7
Reference: ZK1000
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541565035

AU1001,AU1001S,AU1001-96

IVD Class AIVDR 2017/746On the marketInstrumentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565035
Basic UDI-DI: 697454156003KX
Reference: AU1001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Croatia
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541564939

DP4611,DP4612,DP4613,AU17011,AU17012,AU18012,AU18012-96,AU1811,AU1812,AU52111

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564939
Basic UDI-DI: 697454156002KV
Reference: DP4611
EMDN: W01019099
EMDN description: CLINICAL CHEMISTRY REAGENTS - OTHER
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541564724

ST001-1, ST001-2, ST001-3，ST001-4, ST001-5

Class IMDR 2017/745On the marketSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564724
Basic UDI-DI: 69745415618XU
Reference: ST001-1
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Cyprus
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541564571

BTK-16

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541564571
Basic UDI-DI: 697454156012KY
Reference: BTK-16
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541563420

ZK1000-1, ZK1500-1, ZK1000-5, ZK1500-2, ZK1500-3, ZK1500-4, ZK1500-5

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563420
Basic UDI-DI: 697454156008L9
Reference: ZK1500-2
EMDN: W0105900103
EMDN description: SUPPLEMENTAL NA REAGENTS
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:28

Manufacturer products Authorised representative products Authorised representative actors View details

06974541563246

SS001-1, SS001-2, SS001-3, SS001-4, SS001-5, SS001-6, SS001-7

Class IMDR 2017/745On the marketSingle useSterile

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563246
Basic UDI-DI: 697454156001KT
Reference: SS001-1
EMDN: A1101
EMDN description: SAMPLE COLLECTION NEUTRAL SWABS
First on market country: Italy
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:27

Manufacturer products Authorised representative products Authorised representative actors View details

06974541563185

ST7001-3, ST8001-3, ST9001-3

IVD Class AIVDR 2017/746On the marketReagentSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541563185
Basic UDI-DI: 697454156005L3
Reference: ST7001-3
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 02.07.2026 16:27

Manufacturer products Authorised representative products Authorised representative actors View details