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743 device results listed.

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D-IM4402208HQ

Anti-Müllerian Hormone (AMH) Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402208HQ
Basic UDI-DI: B-IM4402208HQ
Reference: IM4402208
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402207HN

β-HCG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402207HN
Basic UDI-DI: B-IM4402207HN
Reference: IM4402207
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402155HU

GDF-15 Chemiluminescent Immunoassay kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402155HU
Basic UDI-DI: B-IM4402155HU
Reference: IM4402155
EMDN: W0102050211
EMDN description: PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402099JB

Unconjugated Estriol Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402099JB
Basic UDI-DI: B-IM4402099JB
Reference: IM4402099
EMDN: W0102050203
EMDN description: UNCONJUGATED (FREE) ESTRIOL
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402073HR

Pregnancy Associated Plasma Protein-A Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402073HR
Basic UDI-DI: B-IM4402073HR
Reference: IM4402073
EMDN: W0102050210
EMDN description: PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402072HP

Free β-HCG Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402072HP
Basic UDI-DI: B-IM4402072HP
Reference: IM4402072
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4401208HH

Anti-Müllerian Hormone (AMH) Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401208HH
Basic UDI-DI: B-IM4401208HH
Reference: IM4401208
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4401207HF

β-HCG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401207HF
Basic UDI-DI: B-IM4401207HF
Reference: IM4401207
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:16

Manufacturer products Authorised representative products Authorised representative actors View details

β-hCG Test cassette

β-hCG Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-BHCG-402GM
Basic UDI-DI: B-FI-BHCG-402GM
Reference: FI-BHCG-402
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
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

AMH Quantitative Test Kit (Time-Resolved FIA)

FAAMH-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAAMH-402aRP
Basic UDI-DI: B-FAAMH-402aRP
Reference: FAAMH-402a
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
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 Quantitative Test Kit (Time-Resolved FIA)

FAAMH-402a

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAAMH-402aHGMB
Basic UDI-DI: B-FAAMH-402aHGMB
Reference: FAAMH-402a
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
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 Quantitative Test Kit (Time-Resolved FIA)

FAAMH-302a

IVD generalIVDDOn the marketCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-FAAMH-302aRG
Basic UDI-DI: B-FAAMH-302aRG
Reference: FAAMH-302a
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
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 Quantitative Test Kit (Time-Resolved FIA)

FAAMH-302a

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-FAAMH-302aHGLW
Basic UDI-DI: B-FAAMH-302aHGLW
Reference: FAAMH-302a
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
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

Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence)

50T/kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0025Z8
Basic UDI-DI: B-FA0025Z8
Reference: 52027112
EMDN: W0102050215
EMDN description: ANTI-MÛLLERIAN HORMONE
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-FA0019ZD

50T/Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-FA0019ZD
Basic UDI-DI: B-FA0019ZD
Reference: 52027018
EMDN: W0102050206
EMDN description: B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 21:15

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4206008FG

Unconjugated Estriol

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4206008FG
Basic UDI-DI: B-EIM4206008FG
Reference: EIM4206008
EMDN: W0102050202
EMDN description: ESTRIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4206002F4

free β-HCG

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4206002F4
Basic UDI-DI: B-EIM4206002F4
Reference: EIM4206002
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4206001F2

HCG

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4206001F2
Basic UDI-DI: B-EIM4206001F2
Reference: EIM4206001
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4205008F9

Unconjugated Estriol

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4205008F9
Basic UDI-DI: B-EIM4205008F9
Reference: EIM4205008
EMDN: W0102050202
EMDN description: ESTRIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-EIM4205002EV

free β-HCG

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-EIM4205002EV
Basic UDI-DI: B-EIM4205002EV
Reference: EIM4205002
EMDN: W0102050213
EMDN description: FREE BETA HCG (PRENATAL SCREENING)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 13.07.2026 18:52

Manufacturer products Authorised representative products Authorised representative actors View details