Calcitonin (CLIA)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4405060 EMDN W0102060301

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-IM4405060J5 Basic UDI-DI	Date22 May 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name: Calcitonin (CLIA)
Model / Reference: IM4405060

Primary DI / UDI-DI: D-IM4405060J5
Basic UDI-DI: B-IM4405060J5
EMDN Code: W0102060301 Calcitonin

Device Class: Class IVD General
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000014618
Authorised representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Maccura Biotechnology Co., Ltd.

Magnesium Assay Kit (Xylidyl Blue Method)

Class B
Automatic Hematology Analyzer F-DC Diluent

Class A
γ-Glutamyltransferase Assay Kit (Glycylglycine Cyanide Anilide Method)

Class B
Lactic Acid Assay Kit (Lactate Oxidase Method)

Class B
Cholinesterase Assay Kit (Butyrylthiocholine Substrate Method)

Class B
Lactate Dehydrogenase Assay Kit (Lactate Substrate Method)

Class B

See all devices from Maccura Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Microbial Substances
Reagent
Professional Testing

Other properties (6)

Sterile: No
Human Tissues: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No

Sources (1)

EUDAMED 3389e744-22a0-4e46-9649-4cba25d7627a 61 fields · synced 22 Oct 2026