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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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02.08.2026 10:00

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762 device results listed.

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Pregnancy Test Strips

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IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Tianjin New Bay Bioresearch Co., Ltd.
Manufacturer SRN: CN-MF-000040564
UDI-DI: 06934142910085
Basic UDI-DI: B-06934142910085
Reference: 9010
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Northern Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 24.06.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

OneStep Pregnancy Test

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IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Tianjin New Bay Bioresearch Co., Ltd.
Manufacturer SRN: CN-MF-000040564
UDI-DI: 06934142910078
Basic UDI-DI: B-06934142910078
Reference: 10120
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Northern Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 24.06.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

QuikPac OneStep HCG Test

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IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Tianjin New Bay Bioresearch Co., Ltd.
Manufacturer SRN: CN-MF-000040564
UDI-DI: 06934142910061
Basic UDI-DI: B-06934142910061
Reference: 7010
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Northern Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 24.06.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

QuikStrip OneStep HCG Test

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IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Tianjin New Bay Bioresearch Co., Ltd.
Manufacturer SRN: CN-MF-000040564
UDI-DI: 06934142910054
Basic UDI-DI: B-06934142910054
Reference: 9001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Northern Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 24.06.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

TEST DE GROSSESSE DÉ TECTION PRÉCOCE

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IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Tianjin New Bay Bioresearch Co., Ltd.
Manufacturer SRN: CN-MF-000040564
UDI-DI: 06934142910047
Basic UDI-DI: B-06934142910047
Reference: 10156
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: MedEnvoy Global BV
Last updated: 24.06.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Tianjin New Bay Bioresearch Co., Ltd.
Manufacturer SRN: CN-MF-000040564
UDI-DI: 06934142910030
Basic UDI-DI: B-06934142910030
Reference: 10157
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Northern Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 24.06.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: Tianjin New Bay Bioresearch Co., Ltd.
Manufacturer SRN: CN-MF-000040564
UDI-DI: 06934142910016
Basic UDI-DI: B-06934142910016
Reference: 10155
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Northern Ireland
Authorised representative: MedEnvoy Global BV
Last updated: 24.06.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD self-testing devicesNot specifiedOn the marketSingle use

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
UDI-DI: 06934078008528
Basic UDI-DI: B-06934078008528
Reference: WHCG-EM11
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 24.06.2026 11:22

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG Rapid Quantitative Test

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260208401
Basic UDI-DI: B-06933260208401
Reference: BT2202
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:59

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)

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IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205882
Basic UDI-DI: B-06933260205882
Reference: BT0503605
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)

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IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205875
Basic UDI-DI: B-06933260205875
Reference: BT0503604
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)

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IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205868
Basic UDI-DI: B-06933260205868
Reference: BT0503603
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)

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IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205851
Basic UDI-DI: B-06933260205851
Reference: BT0503602
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 24.06.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)

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IVD generalNot specifiedNo longer on the marketSingle use

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000012852
UDI-DI: 06933260205844
Basic UDI-DI: B-06933260205844
Reference: BT0503601
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Netherlands
Authorised representative: Medunion S.L.
Last updated: 24.06.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD generalNot specifiedOn the market

Manufacturer: Aidian Oy
Manufacturer SRN: FI-MF-000023611
UDI-DI: 06438115001201
Basic UDI-DI: B-06438115001201
Reference: 149737
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Finland
Authorised representative: -
Last updated: 23.06.2026 11:07

Manufacturer products View details

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IVD Class BNot specifiedOn the marketSingle use

Manufacturer: BioMaxima Spółka Akcyjna
Manufacturer SRN: PL-MF-000039473
UDI-DI: 05902643958142
Basic UDI-DI: 59026439BRT307JJ
Reference: 1-307-P050
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Poland
Authorised representative: -
Last updated: 21.06.2026 17:11

Manufacturer products View details

GenSure HCG Pregnancy Rapid Test

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

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230036
Basic UDI-DI: 697683823P201600ES
Reference: P2016M02
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

GenSure HCG Pregnancy Rapid Test

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

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230043
Basic UDI-DI: 697683823P201600ES
Reference: P2016M03
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

GenSure HCG Pregnancy Rapid Test

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

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230050
Basic UDI-DI: 697683823P201600ES
Reference: P2016M05
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

GenSure HCG Pregnancy Rapid Test

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

Manufacturer: GenSure Biotech Inc.
Manufacturer SRN: CN-MF-000028354
UDI-DI: 16976838230067
Basic UDI-DI: 697683823P201600ES
Reference: P2016M25
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 21.06.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details