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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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03.08.2026 06:01

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D-697994388Ir0613GDE

LH Luteinizing Hormone Test Kit

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Kangsheng Information Technology (Hangzhou) Co. LTD
Manufacturer SRN: CN-MF-000053775
UDI-DI: D-697994388Ir0613GDE
Basic UDI-DI: B-697994388Ir0613GDE
Reference: Ir061
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: Crealkraft GmbH
Last updated: 17.07.2026 04:24

Manufacturer products Authorised representative products Authorised representative actors View details

Follicle-Stimulating Hormone (FSH) Rapid Test (Urine)

Follicle-Stimulating Hormone (FSH) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646MDOAS000825M
Basic UDI-DI: B-697424646MDOAS000825M
Reference: FSH-1011/FSH-1012/FSH-1013
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 04:08

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone(LH) Rapid Test (Urine)

Luteinizing Hormone(LH) Rapid Test (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646LH001FEGA
Basic UDI-DI: B-697424646LH001FEGA
Reference: LH-1011/LH-1012/LH-1013
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Luteinizing Hormone(LH) Rapid Test Kit (Urine)

Luteinizing Hormone(LH) Rapid Test Kit (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646LH000FCFZ
Basic UDI-DI: B-697424646LH000FCFZ
Reference: LH-1011/LH-1012/LH-1013
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:07

Manufacturer products Authorised representative products Authorised representative actors View details

Human Chorionic Gonadotropin(HCG) Rapid Test (Urine/Serum)

Human Chorionic Gonadotropin(HCG) Rapid Test (Urine/Serum)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HCG005EFQ8
Basic UDI-DI: B-697424646HCG005EFQ8
Reference: HCG-2011/HCG-2012
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

HCG Pregnancy Rapid Test(Urine)

HCG Pregnancy Rapid Test(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HCG004EDPX
Basic UDI-DI: B-697424646HCG004EDPX
Reference: HCG-1011/HCG-1012/HCG-1013
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

"Human Chorionic Gonadotropin(HCG) Rapid Test Kit(Urine/Serum)"

"Human Chorionic Gonadotropin(HCG) Rapid Test Kit(Urine/Serum)"

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HCG002E9NZ
Basic UDI-DI: B-697424646HCG002E9NZ
Reference: HCG-2011/HCG-2012
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

HCG Rapid Test Kit (Urine)

HCG Rapid Test Kit (Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HCG001E7NQ
Basic UDI-DI: B-697424646HCG001E7NQ
Reference: HCG-1011/HCG-1012/HCG-1013
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

Follicle-Stimulating Hormone Rapid Test(Urine)

Follicle-Stimulating Hormone Rapid Test(Urine)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646FSH001K4WT
Basic UDI-DI: B-697424646FSH001K4WT
Reference: FSH-1011/FSH-1012/FSH-1013
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: UnicareQ GmbH
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

HCG-U11(25PCS)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-69717712010788S
Basic UDI-DI: B-69717712010788S
Reference: HCG-U11(25PCS)
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details

Ovulation (LH) Test for Self Testing

strip cassette midstream

IVD self-testing devicesIVDDOn the marketProfessional testingSelf testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990602Q9
Basic UDI-DI: B-693757990602Q9
Reference: LH strip cassette midstream
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Test de grossesse

midstream

IVD self-testing devicesIVDDOn the marketSelf testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990102PG
Basic UDI-DI: B-693757990102PG
Reference: HCG midstream
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy Test for Self Testing

strip cassette

IVD self-testing devicesIVDDOn the marketProfessional testingSelf testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990101PE
Basic UDI-DI: B-693757990101PE
Reference: HCG strip cassette
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Ovulation Test

strip, cassette, dipcard and midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-6909620WHSLH8KD2
Basic UDI-DI: B-6909620WHSLH8KD2
Reference: WH-FT-S0x0201; WH-FT-S0x0202; WH-FT-S0x0203; WH-FT-S0x0207
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

One-Step Pregnancy Test

Strip /Cassette /Dip card /Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-6909620WHSHCG8DGP
Basic UDI-DI: B-6909620WHSHCG8DGP
Reference: WH-FT-S0x0101; WH-FT-S0x0102; WH-FT-S0x0103; WH-FT-S0x0107
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

One-Step FSH Test

Strip; Cassette; Dipcard; Midstream

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: W.H.P.M. Bioresearch & Technology Co., Ltd.
Manufacturer SRN: CN-MF-000003007
UDI-DI: D-6909620WHSFSH9MLB
Basic UDI-DI: B-6909620WHSFSH9MLB
Reference: WH-FT-S0x0301; WH-FT-S0x0302; WH-FT-S0x0303; WH-FT-S0x0307
EMDN: W0102160301
EMDN description: FSH - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

HCG One Step pregnancy Test

1176 002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041047874
Basic UDI-DI: B-62230041047874
Reference: 1176 002
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:30

Manufacturer products Authorised representative products Authorised representative actors View details

HCG One Step pregnancy Test

1176 001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041047706
Basic UDI-DI: B-62230041047706
Reference: 1176 001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:30

Manufacturer products Authorised representative products Authorised representative actors View details

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

1178 001

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041024486
Basic UDI-DI: B-62230041024486
Reference: 1178 001
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:25

Manufacturer products Authorised representative products Authorised representative actors View details

Schwangerschafts-Frühtest

IVD self-testing devicesIVDDOn the marketAnimal tissuesKitSelf testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-600701NA
Basic UDI-DI: B-600701NA
Reference: 600701
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 17.07.2026 03:15

Manufacturer products Authorised representative products Authorised representative actors View details