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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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26.09.2026 11:42

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D-IM4404210HR

Testosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404210HR
Basic UDI-DI: B-IM4404210HR
Reference: IM4404210
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: 14.07.2026 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404209J8

E2 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404209J8
Basic UDI-DI: B-IM4404209J8
Reference: IM4404209
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404203HU

PRL (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404203HU
Basic UDI-DI: B-IM4404203HU
Reference: IM4404203
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404202HS

LH (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404202HS
Basic UDI-DI: B-IM4404202HS
Reference: IM4404202
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404208J6

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-IM4404208J6
Basic UDI-DI: B-IM4404208J6
Reference: IM4404208
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 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404204HW

FSH (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404204HW
Basic UDI-DI: B-IM4404204HW
Reference: IM4404204
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 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404201HQ

Ferritin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404201HQ
Basic UDI-DI: B-IM4404201HQ
Reference: IM4404201
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404154J8

NT-proBNP (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404154J8
Basic UDI-DI: B-IM4404154J8
Reference: IM4404154
EMDN: W01021301
EMDN description: BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404153J6

cTnI (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404153J6
Basic UDI-DI: B-IM4404153J6
Reference: IM4404153
EMDN: W01021306
EMDN description: TROPONIN I/T
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404152J4

CK-MB (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404152J4
Basic UDI-DI: B-IM4404152J4
Reference: IM4404152
EMDN: W01021311
EMDN description: CREATINE KINASE - MB MASS (IC)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404151J2

MYO (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404151J2
Basic UDI-DI: B-IM4404151J2
Reference: IM4404151
EMDN: W01021304
EMDN description: MYOGLOBIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404059JD

Tg (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404059JD
Basic UDI-DI: B-IM4404059JD
Reference: IM4404059
EMDN: W01020408
EMDN description: THYROGLOBULIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404057J9

Anti-TPO (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404057J9
Basic UDI-DI: B-IM4404057J9
Reference: IM4404057
EMDN: W0102100301
EMDN description: THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404056J7

Anti-TG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404056J7
Basic UDI-DI: B-IM4404056J7
Reference: IM4404056
EMDN: W0102100303
EMDN description: THYROGLOBULIN AUTOANTIBODY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404055J5

TSH (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404055J5
Basic UDI-DI: B-IM4404055J5
Reference: IM4404055
EMDN: W0102100302
EMDN description: TSH RECEPTOR ANTIBODIES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404054J3

FT4 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404054J3
Basic UDI-DI: B-IM4404054J3
Reference: IM4404054
EMDN: W01020402
EMDN description: FREE THYROXINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404053HZ

total T4 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404053HZ
Basic UDI-DI: B-IM4404053HZ
Reference: IM4404053
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404052HX

FT3 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404052HX
Basic UDI-DI: B-IM4404052HX
Reference: IM4404052
EMDN: W01020401
EMDN description: FREE TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404051HV

total T3 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404051HV
Basic UDI-DI: B-IM4404051HV
Reference: IM4404051
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4404007HS

Calcitonin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4404007HS
Basic UDI-DI: B-IM4404007HS
Reference: IM4404007
EMDN: W0102060301
EMDN description: CALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details