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Maintenance Solution B

EUDAMED

Class A (EU MDR)

Ref 105-062998-00

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

Identity

Trade Name
Maintenance Solution B EUDAMED
Device Name
Maintenance Solution B EUDAMED
Model / Reference
105-062998-00 EUDAMED

Identifiers

Primary DI / UDI-DI
06903053150217 EUDAMED
Basic UDI-DI
69449040AB740007665 EUDAMED
EMDN Code
W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Maintenance Solution B by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000014156
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 99ed5097-d36c-4ff8-9b52-c3b7d5ec744d 61 fields · synced Jun 19, 2026