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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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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

Manufacturer products Authorised representative products Authorised representative actors View details

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

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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

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Schwangerschaftstests 3 mal Gewissheit

CB9/CB11/CB16

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

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08006530454193
Basic UDI-DI: 4084500CB9/CB11/CB16XN
Reference: 08006530454193
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 21.07.2026 15:20

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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: 08006530340786
Basic UDI-DI: 4084500CB14/CB9TL
Reference: 08006530340786
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Ireland
Authorised representative: MDSS GmbH
Last updated: 21.07.2026 15:20

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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: 08006530255202
Basic UDI-DI: 4084500CB16QX
Reference: 08006530255202
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

Ultra Early & Rapid Pregnancy Tests

CB11/CB14

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

Manufacturer: SPD Swiss Precision Diagnostics GmbH
Manufacturer SRN: CH-MF-000025175
UDI-DI: 08006530244442
Basic UDI-DI: 4084500CB11/CB14Q8
Reference: 08006530244442
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

HCG Pregnancy Rapid Test Cassette (Serum, Plasma and Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723354
Basic UDI-DI: B-62230182723354
Reference: D-787 001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 20.07.2026 04:47

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit(Colloidal Gold)

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020140232
Basic UDI-DI: 6936020120BRB
Reference: HCG10-01-1t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

Strip；Cassette；Midstream

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020106900
Basic UDI-DI: 69360201208J
Reference: HCG-02-50t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:58

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020109376
Basic UDI-DI: 69360201208J
Reference: HCG-01-1t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details

Singclean®

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
UDI-DI: 06936020109383
Basic UDI-DI: 69360201208J
Reference: HCG-02-1t
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: -
Authorised representative: Obelis s.a.
Last updated: 19.07.2026 07:56

Manufacturer products Authorised representative products Authorised representative actors View details