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Fully-Automatic Chemiluminescence Immunoassay Analyzer

EUDAMED

Class A (EU MDR)

Ref Wan200+ AModel Wan200+Ref Wan100Ref Wan600 AModel Wan600

by Xiamen United Medical Instruments Co., Ltd.

Identity

Device Name
Fully-Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
Model / Reference
Wan200+ EUDAMED
Wan200+ A EUDAMED
Wan100 EUDAMED
Wan600 EUDAMED
Wan600 A EUDAMED

Identifiers

Primary DI / UDI-DI
06973597100092 EUDAMED
06973597100078 EUDAMED
06973597100382 EUDAMED
Basic UDI-DI
697359710Wan200+GK EUDAMED
697359710Wan1006J EUDAMED
697359710Wan6007B EUDAMED
Direct Marketing DI
06973597100092 EUDAMED
06973597100078 EUDAMED
EMDN Code
W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h) EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Belgium 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

EUDAMEDEUDAMED

Fully-Automatic Chemiluminescence Immunoassay Analyzer by Xiamen United Medical Instruments Co., Ltd. — Class A — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Xiamen United Medical Instruments Co., Ltd.
EUDAMED SRN
CN-MF-000028165
Authorised Representative
QbD RepS BV BE-AR-000000040

Sources (3)

  • EUDAMED 3492f87f-5135-42d0-887d-4765f034227c 61 fields · synced Jul 20, 2026
  • EUDAMED e63e424f-b189-4546-a550-865d046aa286 61 fields · synced May 17, 2026
  • EUDAMED 6abc3bb3-c48a-4ed4-a5d3-d83e7e610f15 61 fields · synced May 19, 2026