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Urine Analyzer

EUDAMED

Class A (EU MDR)

Ref AUR-600Model InstrumentRef AUR-200Ref AUR-401Ref AUR-300Ref AUR-601

by Hangzhou Alltest Biotech.Co., Ltd.

Identity

Trade Name
Urine Analyzer EUDAMED
Device Name
Urine Analyzer EUDAMED
Model / Reference
Instrument EUDAMED
AUR-600 EUDAMED
AUR-200 EUDAMED
AUR-401 EUDAMED
AUR-300 EUDAMED
AUR-601 EUDAMED

Identifiers

Primary DI / UDI-DI
06936983192293 EUDAMED
06970277514620 EUDAMED
06936983185066 EUDAMED
06936983107464 EUDAMED
06942598205433 EUDAMED
Basic UDI-DI
6970277510021VZ2 EUDAMED
6970277510002QYH EUDAMED
Direct Marketing DI
06936983192293 EUDAMED
06970277514620 EUDAMED
06936983185066 EUDAMED
06936983107464 EUDAMED
06942598205433 EUDAMED
EMDN Code
W02010701 URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED
Ireland 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

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Urine Analyzer by Hangzhou Alltest Biotech.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-000010710
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (5)

  • EUDAMED 69c575c8-28d2-4f5d-a704-d9b8f398f89d 61 fields · synced Jul 26, 2026
  • EUDAMED 20a4a0ea-ba1e-409d-988b-ab90857b1e94 61 fields · synced May 16, 2026
  • EUDAMED 3b90eb4d-b734-4a7d-a456-33525efd0987 61 fields · synced May 18, 2026
  • EUDAMED d9f95215-bc68-42dd-b5f6-ffecf5546dc4 61 fields · synced May 18, 2026
  • EUDAMED c5f03ced-28e6-4c3b-9bc3-1cc4daa4bb8f 61 fields · synced Jul 13, 2026