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08034049110033

Estradiol ELISA

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testing

Manufacturer: Dia.Metra Srl
Manufacturer SRN: IT-MF-000027206
UDI-DI: 08034049110033
Basic UDI-DI: 8034049110033U6
Reference: DKO003
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Italy
Authorised representative: -
Last updated: 03.07.2026 08:24

Manufacturer products View details

Estradiol Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

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

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465235371
Basic UDI-DI: 697846523HormoneB09J7
Reference: 2×100 test
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

Manufacturer products Authorised representative products Authorised representative actors View details

Pylon Estradiol

40 tests/kit 100 tests/kit 200 tests/kit

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: ET Healthcare (Suzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000039448
UDI-DI: 06976485025484
Basic UDI-DI: 697648502E23A
Reference: 10-2237 40 tests/kit
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: -
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 02.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

HOKAPI™ ESTRADIOL

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Suzhou Hokapi Biomedical Engineering Co., Ltd..
Manufacturer SRN: CN-MF-000013723
UDI-DI: 06939716405059
Basic UDI-DI: 69713904304147Z
Reference: 010414001
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: France
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 02.07.2026 11:54

Manufacturer products Authorised representative products Authorised representative actors View details

IDS Estradiol

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Immunodiagnostic Systems Limited
Manufacturer SRN: GB-MF-000015851
UDI-DI: 05060169690745
Basic UDI-DI: 5060169690745XL
Reference: IS-5200
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Belgium
Authorised representative: Immunodiagnostic Systems SA
Last updated: 02.07.2026 02:06

Manufacturer products Authorised representative products Authorised representative actors View details

17beta-Estradiol Saliva ELISA

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325030558
Basic UDI-DI: 4049325IVR06080010BTH
Reference: 30121045
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 19:04

Manufacturer products View details

17beta-Estradiol Saliva Luminescence Immunoassay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325030534
Basic UDI-DI: 4049325IVR06080011BTL
Reference: RE62141
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: -
Last updated: 01.07.2026 19:04

Manufacturer products View details

Access Sensitive Estradiol

B84493

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590699383
Basic UDI-DI: 150995901AccSE2MT
Reference: B84493
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

Manufacturer products Authorised representative products Authorised representative actors View details

17beta-Estradiol Saliva Luminescence Immunoassay

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325030541
Basic UDI-DI: 4049325IVR06080011BTL
Reference: RE62149
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: -
Authorised representative: -
Last updated: 30.06.2026 12:40

Manufacturer products View details

Estradiol (E2) Assay Kit (Chemiluminescent Immunoassay)

2×50 test/box Calibrator:0.5mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06970522649831
Basic UDI-DI: B-06970522649831
Reference: CL1003
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 30.06.2026 04:48

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol (CLIA)

IVD Class BNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053118606
Basic UDI-DI: 69449040AB740006866
Reference: 105-055510-00
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol (CLIA)

IVD Class BNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053164092
Basic UDI-DI: 69449040AB740006866
Reference: 105-066936-00
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol (CLIA)

IVD Class BNot specifiedOn the market

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053164108
Basic UDI-DI: 69449040AB740006866
Reference: 105-066937-00
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:10

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701380
Basic UDI-DI: B-06955792701380
Reference: S2085E-24
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol Assay Kit (Chemiluminescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792701373
Basic UDI-DI: B-06955792701373
Reference: S2085E-48
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:20

Manufacturer products Authorised representative products Authorised representative actors View details

MAGICL Estradiol (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414798142
Basic UDI-DI: B-06954414798142
Reference: /
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Türkiye
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:32

Manufacturer products Authorised representative products Authorised representative actors View details

Estradiol Fast Test Kit (Immunofluorescence Assay)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Getein Biotech, Inc.
Manufacturer SRN: CN-MF-000017986
UDI-DI: 06954414702620
Basic UDI-DI: B-06954414702620
Reference: /
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Netherlands
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 18:26

Manufacturer products Authorised representative products Authorised representative actors View details

E2 FIA

E2-W23F3

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804803261
Basic UDI-DI: B-06952804803261
Reference: E2-W23F3
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 12:24

Manufacturer products Authorised representative products Authorised representative actors View details

06950617400806

IM4402209 IM4403209 IM4406209 IM4407209

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617400806
Basic UDI-DI: 69506174IM440209DG
Reference: IM4407209
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:34

Manufacturer products Authorised representative products Authorised representative actors View details

06950617400790

IM4402209 IM4403209 IM4406209 IM4407209

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617400790
Basic UDI-DI: 69506174IM440209DG
Reference: IM4406209
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:33

Manufacturer products Authorised representative products Authorised representative actors View details