Anti-TPO (CLIA)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4401057 EMDN W0102100301

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-IM4401057HL 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Withdrawn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 25 Oct 2026

Device Name: Anti-TPO (CLIA)
Model / Reference: IM4401057

Primary DI / UDI-DI: D-IM4401057HL
Basic UDI-DI: B-IM4401057HL
EMDN Code: W0102100301 Thyroid peroxidase (incl. microsomal) antibodies

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

Animal Tissues
Reagent
Professional Testing

Other properties (7)

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

Sources (1)

EUDAMED 86584f87-7425-47cd-8b92-183813c1c533 61 fields · synced 25 Oct 2026