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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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E2 Detection Kit (Immunofluorescence Chromatography)

E2 Detection Kit (Immunofluorescence Chromatography)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD175XV
Basic UDI-DI: B-GKPD175XV
Reference: GKPD175
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

Male Fertility Rapid Test Cassette (Semen)

GASPE-902a

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GASPE-902aHG9A
Basic UDI-DI: B-GASPE-902aHG9A
Reference: GASPE-902a
EMDN: W0102050199
EMDN description: FERTILITY FUNCTION HORMONES - OTHER
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Ovulation Test Cassette (Urine)

GALH-102b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-102bVY
Basic UDI-DI: B-GALH-102bVY
Reference: GALH-102b
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:14

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Ovulation Test Cassette (Urine)

GALH-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-102aVW
Basic UDI-DI: B-GALH-102aVW
Reference: GALH-102a
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Ovulation Test Strip (Urine)

GALH-101b

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-101bVV
Basic UDI-DI: B-GALH-101bVV
Reference: GALH-101b
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Ovulation Test Strip (Urine)

GALH-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GALH-101aVT
Basic UDI-DI: B-GALH-101aVT
Reference: GALH-101a
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Menopause Test Midstream (Urine)

GAFSH-103a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GAFSH-103aY7
Basic UDI-DI: B-GAFSH-103aY7
Reference: GAFSH-103a
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Menopause Test Midstream (Urine)

GAFSH-103a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GAFSH-103aHGWB
Basic UDI-DI: B-GAFSH-103aHGWB
Reference: GAFSH-103a
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Menopause Test Cassette (Urine)

GAFSH-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GAFSH-102aY4
Basic UDI-DI: B-GAFSH-102aY4
Reference: GAFSH-102a
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Menopause Test Cassette (Urine)

GAFSH-102a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GAFSH-102aHGW4
Basic UDI-DI: B-GAFSH-102aHGW4
Reference: GAFSH-102a
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Menopause Test Strip (Urine)

GAFSH-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GAFSH-101aXZ
Basic UDI-DI: B-GAFSH-101aXZ
Reference: GAFSH-101a
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Menopause Test Strip (Urine)

GAFSH-101a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GAFSH-101aHGVV
Basic UDI-DI: B-GAFSH-101aHGVV
Reference: GAFSH-101a
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:02

Manufacturer products Authorised representative products Authorised representative actors View details

FT Free Testosterone (CLIA)

FT Free Testosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-FTesto706-AED3
Basic UDI-DI: B-FTesto706-AED3
Reference: FTesto706-AE10Y, FTesto706-AE10N, FTesto706-AE20Y, FTesto706-AE20N
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 23:29

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Follicle Stimulating Hormone (CLIA)

FSH Follicle Stimulating Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-FSH706-AEYS
Basic UDI-DI: B-FSH706-AEYS
Reference: FSH706-AE10Y, FSH706-AE10N, FSH706-AE20Y, FSH706-AE20N
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 22:12

Manufacturer products Authorised representative products Authorised representative actors View details

TES Quantitative Test Kit (Time-Resolved FIA)

FKTES-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FKTES-402aHGH4
Basic UDI-DI: B-FKTES-402aHGH4
Reference: FKTES-402a
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

TES Quantitative Test Kit (Time-Resolved FIA)

FKTES-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSelf testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKTES-402aCG
Basic UDI-DI: B-FKTES-402aCG
Reference: FKTES-402a
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG Quantitative Test Kit (Time-Resolved FIA)

FKSHB-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FKSHB-402aHG89
Basic UDI-DI: B-FKSHB-402aHG89
Reference: FKSHB-402a
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG Quantitative Test Kit (Time-Resolved FIA)

FKSHB-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FKSHB-402a6K
Basic UDI-DI: B-FKSHB-402a6K
Reference: FKSHB-402a
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

LH Test Cassette

LH Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-LH-402RK
Basic UDI-DI: B-FI-LH-402RK
Reference: FI-LH-402
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Test Cassette

FSH Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-FSH-402S7
Basic UDI-DI: B-FI-FSH-402S7
Reference: FI-FSH-402
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 13.07.2026 21:27

Manufacturer products Authorised representative products Authorised representative actors View details