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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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01.08.2026 09:11

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Prolactin test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403183
Basic UDI-DI: 697029753298M7
Reference: HGCL17
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian hormone test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403176
Basic UDI-DI: 697029753077LM
Reference: HGCL14
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

SHBG CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543866
Basic UDI-DI: 697015090000033GX
Reference: CMF0803
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

DHEA-S CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543767
Basic UDI-DI: 697015090000032GV
Reference: CMF0703
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

17α-OHP CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543668
Basic UDI-DI: 697015090000034GZ
Reference: CMF0903
EMDN: W0102050107
EMDN description: 17 OH PROGESTERONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

FSH CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543187
Basic UDI-DI: 697015090000027H4
Reference: CMF0205
EMDN: W0102050104
EMDN description: FOLLICLE STIMULATING HORMONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

LH CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359543088
Basic UDI-DI: 697015090000026H2
Reference: CMF0105
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

Testosterone CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359542982
Basic UDI-DI: 697015090000029H8
Reference: CMF0405
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

PRG CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359542883
Basic UDI-DI: 697015090000031GT
Reference: CMF0605
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

E2 CLIA Microparticles

AutoLumo Analyzer

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359542784
Basic UDI-DI: 697015090000030GR
Reference: CMF0505
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

06951045811479

100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045811479
Basic UDI-DI: 69510458SF_AMHVV
Reference: SY434QG
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

06951045811462

100 tests

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Suzhou Sym-Bio Lifescience Co., Ltd.
Manufacturer SRN: CN-MF-000012847
UDI-DI: 06951045811462
Basic UDI-DI: 69510458SF_PlGFBZ
Reference: SY428QG
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 31.07.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone (CLIA)

105-010711-00、105-010738-00、105-018808-00、105-010697-00、105-010724-00、 105-018809-00、105-018810-00、105-018811-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053158701
Basic UDI-DI: 69449040004S-AMH*******7J
Reference: 105-065972-00
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:57

Manufacturer products Authorised representative products Authorised representative actors View details

Progesterone（CLIA）

105-004228-00、105-004255-00、105-004295-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904047829
Basic UDI-DI: 69449040AB74000055E
Reference: 105-004228-00
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol (CLIA)

105-004225-00、105-004252-00、105-004296-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904047799
Basic UDI-DI: 69449040AB74000045C
Reference: 105-004225-00
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:54

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Mullerian Hormone (CLIA)

105-010711-00、105-010738-00、105-018808-00、105-010697-00、105-010724-00、 105-018809-00、105-018810-00、105-018811-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053158695
Basic UDI-DI: 69449040004S-AMH*******7J
Reference: 105-065971-00
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Dehydroepiandrosterone sulfate(CLIA)

105-005674-00、105-005691-00、105-005925-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053157940
Basic UDI-DI: 69449040004L-DHEA-S****PF
Reference: 105-064667-00
EMDN: W0102050102
EMDN description: DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:53

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol (CLIA)

105-055512-00/105-055510-00/105-066936-00/105-066937-00

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053118583
Basic UDI-DI: 69449040AB740006866
Reference: 105-055512-00
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:52

Manufacturer products Authorised representative products Authorised representative actors View details

Free Testosterone (CLIA)

105-043329-00、105-043330-00、105-043332-00 、105-043333-00 、105-043331-00 、105-043334-00、105-043335-00 、105-043337-00 、105-043338-00 、105-043336-00

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053068109
Basic UDI-DI: 69449040AB740005965
Reference: 105-043330-00
EMDN: W0102050110
EMDN description: TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:51

Manufacturer products Authorised representative products Authorised representative actors View details

Sex Hormone Binding Globulin (CLIA)

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053063562
Basic UDI-DI: 69449040AB74000525P
Reference: 105-041714-00
EMDN: W0102050109
EMDN description: SEX HORMONE BINDING GLOBULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details