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Urine Analyzer

EUDAMED

Class A (EU MDR)

Ref WHY140FAModel WHY120FA, WHY130FA, WHY140FA, WHY160FA, WHY170FA&WHY160FA, WHY170FARef WHY170FARef WHY170FA&WHY160FARef WHY160FA

by Nanjing Poweam Medical Co., Ltd

Identity

Trade Name
Urine Analyzer EUDAMED
Device Name
Urine Analyzer EUDAMED
Model / Reference
WHY120FA, WHY130FA, WHY140FA, WHY160FA, WHY170FA&WHY160FA, WHY170FA EUDAMED
WHY140FA EUDAMED
WHY170FA EUDAMED
WHY170FA&WHY160FA EUDAMED
WHY160FA EUDAMED

Identifiers

Primary DI / UDI-DI
06977226450374 EUDAMED
06977226450404 EUDAMED
06977226450398 EUDAMED
06977226450381 EUDAMED
Basic UDI-DI
697722645BTUA01QA EUDAMED
EMDN Code
W020101020102 SEMI-AUTOMATED URINE ANALYSERS EUDAMED
W020101020103 AUTOMATED URINE ANALYSERS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Austria 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

Urine Analyzer by Nanjing Poweam Medical 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

Manufacturer
Nanjing Poweam Medical Co., Ltd
EUDAMED SRN
CN-MF-000040207
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (4)

  • EUDAMED dca96327-1a93-4bde-be47-4cce6399ee90 61 fields · synced Oct 6, 2026
  • EUDAMED ed4b384d-bb96-4d22-94c5-9afae53390de 61 fields · synced May 18, 2026
  • EUDAMED 5ed14121-7bd9-4e36-be3c-b1a954be49f8 61 fields · synced May 19, 2026
  • EUDAMED 0a30f6ae-28d1-41eb-9a14-1240828bb1d8 61 fields · synced May 19, 2026