Progesterone Calibrators

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4282006

EMDN W0102152202

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-EIM4282006H8 Basic UDI-DI	Date22 May 2022Registered	StatusActive

Coverage

1 jurisdiction

Expiring (legacy directive)
Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: Progesterone Calibrators
Model / Reference: EIM4282006

Primary DI / UDI-DI: D-EIM4282006H8
Basic UDI-DI: B-EIM4282006H8
EMDN Code: W0102152202 Hormone standards and calibrators

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.

Complement C4 Assay Kit (Immunoturbidimetric Method)

Class B
25-OH Vitamin D Chemiluminescent Immunoassay Kit

Class B
Complement C3 Assay Kit (Immunoturbidimetric Method)

Class B
Lactic Acid Assay Kit (Lactate Oxidase Method)

Class B
Carbon Dioxide Assay Kit (PEPC Enzymatic Method)

Class B
Urinary Microalbumin Control

Class B

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

Properties & raw data

Show properties, registry sources and raw records

Animal Tissues
Professional Testing

Other properties (8)

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

Sources (1)

EUDAMED 5e168876-1212-441a-a8bc-776ee26b1add 61 fields · synced 24 Oct 2026