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EUDAMED Device Search

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INDICAID™ Ovulation Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A035D2
Basic UDI-DI: B-A035D2
Reference: INDICAID™ Ovulation Rapid Test
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 18:17

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INDICAID™ Rapid Pregnancy Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Phase Scientific International Limited
Manufacturer SRN: HK-MF-000025791
UDI-DI: D-A033CW
Basic UDI-DI: B-A033CW
Reference: INDICAID™ Rapid Pregnancy Test
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 24.07.2026 18:17

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Ultra Early & Weeks Indicator Pregnancy Tests

CB14/CB9A

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

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08006530601023
Basic UDI-DI: 4084500CB14/CB9TL
Reference: 08006530601023
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 24.07.2026 13:49

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Ultra Early Advanced Pregnancy Test

CB16

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

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08006530242813
Basic UDI-DI: 4084500CB16QX
Reference: 08006530242813
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 24.07.2026 13:49

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Ultra Early Advanced Pregnancy Test

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

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08006530242820
Basic UDI-DI: 4084500CB16QX
Reference: 08006530242820
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 24.07.2026 13:47

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Ultra Early Advanced Pregnancy Test

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

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08006530242851
Basic UDI-DI: 4084500CB16QX
Reference: 08006530242851
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 24.07.2026 13:47

Manufacturer products Authorised representative products Authorised representative actors View details

Ultra Early & Weeks Indicator Pregnancy Tests

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

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08006540471081
Basic UDI-DI: 4084500CB14/CB9TL
Reference: 08006540471081
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: MDSS GmbH
Last updated: 24.07.2026 13:47

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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: 06957290301345
Basic UDI-DI: B-06957290301345
Reference: HCG-M35(2 Tests/Kit)
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: Sungo Cert GmbH
Last updated: 24.07.2026 06:53

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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: 06957290301338
Basic UDI-DI: B-06957290301338
Reference: HCG-M35(1 Test/Kit)
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: Sungo Cert GmbH
Last updated: 24.07.2026 06:53

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SPERM TEST

IVD self-testing devicesIVDDOn the marketKitSelf testingSingle use

Manufacturer: PRIMA Lab SA
Manufacturer SRN: CH-MF-000034473
UDI-DI: D-100082-1ACVH
Basic UDI-DI: B-100082-1ACVH
Reference: 100082-x
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 24.07.2026 00:38

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hCG (Human Chorionic Gonadotropin) Rapid Test (Urine)

WHC-4013

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750631
Basic UDI-DI: B-06974785750631
Reference: WHC-4013
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 23.07.2026 06:55

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BIOSYNEX

Midstream

IVD Class BIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Chembio Biosynex Diagnostics (Hangzhou) Inc.
Manufacturer SRN: CN-MF-000039047
UDI-DI: 06977005880057
Basic UDI-DI: 697700588C00002OZK
Reference: 860063
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Iceland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 16:48

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BIOSYNEX

Midstream

IVD Class BIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Chembio Biosynex Diagnostics (Hangzhou) Inc.
Manufacturer SRN: CN-MF-000039047
UDI-DI: 06977005880033
Basic UDI-DI: 697700588C00001OZG
Reference: 860061
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 16:48

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX

IVD Class BIVDR 2017/746On the marketKitReagentSelf testingSingle use

Manufacturer: Chembio Biosynex Diagnostics (Hangzhou) Inc.
Manufacturer SRN: CN-MF-000039047
UDI-DI: 06977005880088
Basic UDI-DI: 697700588C00002OZK
Reference: 858931
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 22.07.2026 16:48

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H. pylori Antibody Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHP-402(AT)AE
Basic UDI-DI: B-IHP-402(AT)AE
Reference: IHP-402
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Pregnancy Rapid Test Dipstick

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FHC-201(AT)UN
Basic UDI-DI: B-FHC-201(AT)UN
Reference: FHC-201
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 22.07.2026 06:36

Manufacturer products Authorised representative products Authorised representative actors View details

Ultra raný Těhotenský 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: 08001841550701
Basic UDI-DI: 4084500CB14QT
Reference: 08001841550701
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Czechia
Authorised representative: MDSS GmbH
Last updated: 21.07.2026 15:48

Manufacturer products Authorised representative products Authorised representative actors View details

Digital Ultra Early Pregnancy Test

CB15

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

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08001841804248
Basic UDI-DI: 4084500CB15QV
Reference: 08001841804248
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 21.07.2026 15:48

Manufacturer products Authorised representative products Authorised representative actors View details

Easy 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: 08006530474245
Basic UDI-DI: 4084500CB11/CB11AUR
Reference: 08006530474245
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 21.07.2026 15:20

Manufacturer products Authorised representative products Authorised representative actors View details

Test Early & Date Pregnancy Tests

CB9/CB16

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

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08006530454292
Basic UDI-DI: 4084500CB9/CB16XF
Reference: 08006530454292
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 21.07.2026 15:20

Manufacturer products Authorised representative products Authorised representative actors View details