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Auto Stainer

EUDAMED

Class A (EU MDR)

Ref BSZ-GTl16Model BSJ-DB228

by Baso Diagnostics Inc. Zhuhai

Identity

Trade Name
Auto Stainer EUDAMED
Device Name
Auto-Stainer EUDAMED
Model / Reference
BSJ-DB228 EUDAMED
BSZ-GTl16 EUDAMED

Identifiers

Primary DI / UDI-DI
06952383305729 EUDAMED
Basic UDI-DI
695238330006GM EUDAMED
Direct Marketing DI
06952383305729 EUDAMED
EMDN Code
W0202059002 AUTOMATED SLIDE STAINERS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Auto Stainer by Baso Diagnostics Inc. Zhuhai — 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-000050424
Authorised Representative
Eunitor GmbH DE-AR-000005081

Sources (2)

  • EUDAMED 73105f5c-47b0-42c0-87bd-c4a1bc42b484 61 fields · synced Jun 19, 2026
  • EUDAMED 7e063937-897b-495e-bff7-c53249e4dfe2 61 fields · synced Jun 19, 2026