Fructosamine (FMN)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref ECH0101103, ECH0102103, ECH0105103

EMDN W01010210

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-ECH01011034E 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 22 Oct 2026

Device Name: Fructosamine (FMN)
Model / Reference: ECH0101103, ECH0102103, ECH0105103

Primary DI / UDI-DI: D-ECH01011034E, D-ECH01021034M, D-ECH01051035A
Basic UDI-DI: B-ECH01011034E, B-ECH01021034M, B-ECH01051035A
EMDN Code: W01010210 Fructosamine

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

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Properties & raw data

Show properties, registry sources and raw records

Reagent
Professional Testing

Other properties (8)

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

Sources (3)

EUDAMED e46b8db1-44c3-4243-b0eb-761d02ddb1b2 61 fields · synced 22 Oct 2026
EUDAMED 1d5785e3-9617-4d19-8aae-1a20a5db5040 61 fields · synced 17 May 2026
EUDAMED 4712f881-2f41-4c80-ae5c-cb3d0a034d44 61 fields · synced 19 May 2026