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D-IM4409258KQ

Anti-SSB(La) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4409258KQ
Basic UDI-DI: B-IM4409258KQ
Reference: IM4409258
EMDN: W0102100113
EMDN description: SS-B
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4409256KL

Anti-SSA(Ro60) Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4409256KL
Basic UDI-DI: B-IM4409256KL
Reference: IM4409256
EMDN: W0102100112
EMDN description: SS-A
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4409255KJ

Anti-Sm Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4409255KJ
Basic UDI-DI: B-IM4409255KJ
Reference: IM4409255
EMDN: W0102100111
EMDN description: SM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4409254KG

Anti-Sm/RNP Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4409254KG
Basic UDI-DI: B-IM4409254KG
Reference: IM4409254
EMDN: W0102100199
EMDN description: AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408351K8

25-OH Vitamin D Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408351K8
Basic UDI-DI: B-IM4408351K8
Reference: IM4408351
EMDN: W0102060309
EMDN description: 25-HYDROXYVITAMIN D
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408301JR

PCT (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408301JR
Basic UDI-DI: B-IM4408301JR
Reference: IM4408301
EMDN: W0102069013
EMDN description: PROCALCITONIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408251K3

Anti-CCP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408251K3
Basic UDI-DI: B-IM4408251K3
Reference: IM4408251
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408210JM

Testosterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408210JM
Basic UDI-DI: B-IM4408210JM
Reference: IM4408210
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 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408209K4

E2 (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408209K4
Basic UDI-DI: B-IM4408209K4
Reference: IM4408209
EMDN: W0102050103
EMDN description: ESTRADIOL
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408206JW

human Growth Hormone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408206JW
Basic UDI-DI: B-IM4408206JW
Reference: IM4408206
EMDN: W0102060402
EMDN description: HUMAN GROWTH HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408208K2

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-IM4408208K2
Basic UDI-DI: B-IM4408208K2
Reference: IM4408208
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 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408207JY

β-HCG (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408207JY
Basic UDI-DI: B-IM4408207JY
Reference: IM4408207
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 01:30

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408205JU

Progesterone (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408205JU
Basic UDI-DI: B-IM4408205JU
Reference: IM4408205
EMDN: W0102050106
EMDN description: PROGESTERONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408204JS

FSH (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408204JS
Basic UDI-DI: B-IM4408204JS
Reference: IM4408204
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 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408203JQ

PRL (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408203JQ
Basic UDI-DI: B-IM4408203JQ
Reference: IM4408203
EMDN: W0102050108
EMDN description: PROLACTIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408202JN

LH (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408202JN
Basic UDI-DI: B-IM4408202JN
Reference: IM4408202
EMDN: W0102050105
EMDN description: LUTEINISING HORMONE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408201JL

Ferritin (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408201JL
Basic UDI-DI: B-IM4408201JL
Reference: IM4408201
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408154K4

NT-proBNP (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408154K4
Basic UDI-DI: B-IM4408154K4
Reference: IM4408154
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 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408153K2

cTnI (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408153K2
Basic UDI-DI: B-IM4408153K2
Reference: IM4408153
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 01:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4408152JY

CK-MB (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4408152JY
Basic UDI-DI: B-IM4408152JY
Reference: IM4408152
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 01:29

Manufacturer products Authorised representative products Authorised representative actors View details