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936 device results listed.

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hCG Pregnancy Test Kit (CLIA)

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-CI-HCG(AT)M7
Basic UDI-DI: B-CI-HCG(AT)M7
Reference: CI-HCG
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 21.09.2026 17:12

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hCG Pregnancy Enhanced Sensitivity Rapid Test Midstream

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FHC-U103H(ACRO)QV
Basic UDI-DI: B-FHC-U103H(ACRO)QV
Reference: FHC-U103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

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hCG Pregnancy Rapid Test Midstream

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FHC-103H(ACRO)UY
Basic UDI-DI: B-FHC-103H(ACRO)UY
Reference: FHC-103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

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Digital Early Pregnancy Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FHC-ACOEU103H46
Basic UDI-DI: B-FHC-ACOEU103H46
Reference: FHC-ACOEU103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:45

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Digital hCG Pregnancy Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FHC-ACOE103HPB
Basic UDI-DI: B-FHC-ACOE103HPB
Reference: FHC-ACOE103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:45

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D-FHC-RU1023J

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FHC-RU1023J
Basic UDI-DI: B-FHC-RU1023J
Reference: FHC-RU102
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:00

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HCG Pregnancy Rapid Tests

WHCG2001, WHCG2002, WHCG2004, WHCG2003

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-WHCG2002M
Basic UDI-DI: B-WHCG2002M
Reference: WHCG2001, WHCG2002, WHCG2004,WHCG2003
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

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HCG Pregnancy Rapid Tests

WHCG1001, WHCG1002, WHCG1003

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-WHCG1002G
Basic UDI-DI: B-WHCG1002G
Reference: WHCG1001, WHCG1002, WHCG1003
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

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Schwangerschaftstest mit Wochenbestimmung

CB9

IVD Class BIVDR 2017/746On the marketAnimal tissuesInstrumentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08006530600934
Basic UDI-DI: 4084500CB985
Reference: 08006530600934
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Austria
Authorised representative: MDSS GmbH
Last updated: 08.08.2026 10:42

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Advanced Fertilitätsmonitor Teststäbchen

FAM 1.1

IVD self-testing devicesIVDDOn the marketAnimal tissuesInstrumentReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08006540807439
Basic UDI-DI: B-08006540807439
Reference: 08006540807439
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 08.08.2026 10:39

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Schwangerschaftstests Frühe Erkennung und mit Wochenbestimmung Kombipack

CB14/CB9

IVD self-testing devicesIVDDOn the marketAnimal tissuesInstrumentKitReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08700216659888
Basic UDI-DI: B-08700216659888
Reference: 08700216659888
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 07.08.2026 21:09

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Tests de grossesse Testez et confirmez

CB14/CB9

IVD self-testing devicesIVDDOn the marketAnimal tissuesInstrumentKitReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08700216455886
Basic UDI-DI: B-08700216455886
Reference: 08700216455886
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: MDSS GmbH
Last updated: 07.08.2026 21:07

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Rapid Detection Pregnancy Test

CB11/CB11A

IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 04084500477445
Basic UDI-DI: 4084500CB11/CB11AUR
Reference: 04084500477445
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 07.08.2026 19:53

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Moniteur de Fertilité Avancé

FAM 1.1

IVD self-testing devicesIVDDOn the marketAnimal tissuesInstrumentReagentSelf testing

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 04084500851153
Basic UDI-DI: B-04084500851153
Reference: 04084500851153
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Italy
Authorised representative: MDSS GmbH
Last updated: 07.08.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Fertilitetsmonitor Advanced Påfyllnadstester

FAM 1.1

IVD self-testing devicesIVDDOn the marketAnimal tissuesInstrumentReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 04084500031814
Basic UDI-DI: B-04084500031814
Reference: 04084500031814
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Norway
Authorised representative: MDSS GmbH
Last updated: 07.08.2026 19:51

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Rapid Detection Pregnancy Test

IVD Class BNot specifiedOn the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 04084500477520
Basic UDI-DI: 4084500CB11/CB11AUR
Reference: 04084500477520
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 07.08.2026 19:49

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Pregnancy testing kit-(7.0mm)

Midstream（1test/box）

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Nantong Diagnos Biotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000041526
UDI-DI: 06934592100166
Basic UDI-DI: B-06934592100166
Reference: AE69
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: Kingsmead Service B.V.
Last updated: 07.08.2026 06:49

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Ultra Early Pregnancy Test

CB14

IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08700216335102
Basic UDI-DI: 4084500CB14QT
Reference: 08700216335102
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 05.08.2026 15:54

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid Detection Pregnancy Test

CB11/CB11A

IVD Class BIVDR 2017/746On the marketAnimal tissuesReagentSelf testingSingle use

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08700216287883
Basic UDI-DI: 4084500CB11/CB11AUR
Reference: 08700216287883
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 05.08.2026 15:54

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Docteur B

Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Hubei MEIBAO Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000019986
UDI-DI: 26957290300168
Basic UDI-DI: B-26957290300168
Reference: HCG-M35D02(2 Tests/Kit)
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: Sungo Cert GmbH
Last updated: 05.08.2026 15:24

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