Cleaning Solution

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED

Ref 105-005732-00Model 105-007856-00

EMDN W0103080599

Regulatory status

as of 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number69449040XQSJ-003Xhemo**HV Basic UDI-DI	Date26 Apr 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name: Hemoglobin A1c Reagent
Model / Reference: 105-007856-00, 105-005732-00

Primary DI / UDI-DI: 06944904052410
Basic UDI-DI: 69449040XQSJ-003Xhemo**HV
EMDN Code: W0103080599 Auxiliary & supplemental reagents for flow cytometry - other

Device Class: Class A
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000014156
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 (9)

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

Sources (1)

EUDAMED acd2add0-5305-42b9-b98c-524aa101e0f5 61 fields · synced 23 Oct 2026