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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 18:01

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FSH Control

FAFSH-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAFSH-PN20HGCG
Basic UDI-DI: B-FAFSH-PN20HGCG
Reference: FAFSH-PN20
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

FSH Control

FAFSH-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAFSH-PN207P
Basic UDI-DI: B-FAFSH-PN207P
Reference: FAFSH-PN20
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

E2 Control

FAE2-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAE2-PN20RC
Basic UDI-DI: B-FAE2-PN20RC
Reference: FAE2-PN20
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

E2 Control

FAE2-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAE2-PN20HGER
Basic UDI-DI: B-FAE2-PN20HGER
Reference: FAE2-PN20
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Control

FAAMH-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAAMH-PN20ZF
Basic UDI-DI: B-FAAMH-PN20ZF
Reference: FAAMH-PN20
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

AMH Control

FAAMH-PN20

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAAMH-PN20HG3M
Basic UDI-DI: B-FAAMH-PN20HG3M
Reference: FAAMH-PN20
EMDN: W0102152002
EMDN description: HORMONE CONTROLS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4498112KP

proGRP Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4498112KP
Basic UDI-DI: B-EIM4498112KP
Reference: EIM4498112
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4497112KG

proGRP Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substances

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4497112KG
Basic UDI-DI: B-EIM4497112KG
Reference: EIM4497112
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4492115JK

HE4 Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4492115JK
Basic UDI-DI: B-EIM4492115JK
Reference: EIM4492115
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4492114JH

CA 242 Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4492114JH
Basic UDI-DI: B-EIM4492114JH
Reference: EIM4492114
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4492113JF

CA72-4 Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4492113JF
Basic UDI-DI: B-EIM4492113JF
Reference: EIM4492113
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4491115JC

HE4 Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4491115JC
Basic UDI-DI: B-EIM4491115JC
Reference: EIM4491115
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4491114JA

CA 242 Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4491114JA
Basic UDI-DI: B-EIM4491114JA
Reference: EIM4491114
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4491113J8

CA72-4 Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4491113J8
Basic UDI-DI: B-EIM4491113J8
Reference: EIM4491113
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:58

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4299106K9

Tumor Marker Control

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4299106K9
Basic UDI-DI: B-EIM4299106K9
Reference: EIM4299106
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4298505KL

Insulin & C-Peptide Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4298505KL
Basic UDI-DI: B-EIM4298505KL
Reference: EIM4298505
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4298112JV

CA50 Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4298112JV
Basic UDI-DI: B-EIM4298112JV
Reference: EIM4298112
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4298111JT

SCC Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4298111JT
Basic UDI-DI: B-EIM4298111JT
Reference: EIM4298111
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4298109K8

CYFRA21-1 Control

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4298109K8
Basic UDI-DI: B-EIM4298109K8
Reference: EIM4298109
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 13.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4298106K2

Tumor Marker Control

IVD Annex II List BIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testing

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4298106K2
Basic UDI-DI: B-EIM4298106K2
Reference: EIM4298106
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:57

Manufacturer products Authorised representative products Authorised representative actors View details