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Hematology Reagent - Diluent

EUDAMED

Class A (EU MDR)

Ref 0320900405Model 2L, 5L, 10L, 20LRef 0320900407Ref 0320900402Model W-31D：2L, 5L, 10L, 20LRef 0320900409

by Wheisman Medical Technology Co., Ltd.

Identity

Trade Name
Hematology Reagent - Diluent EUDAMED
Device Name
Hematology Reagent - Diluent EUDAMED
Model / Reference
2L, 5L, 10L, 20L EUDAMED
0320900405 EUDAMED
0320900407 EUDAMED
W-31D：2L, 5L, 10L, 20L EUDAMED
0320900402 EUDAMED
0320900409 EUDAMED

Identifiers

Primary DI / UDI-DI
06976578180465 EUDAMED
06976578180489 EUDAMED
06976578180045 EUDAMED
06976578180540 EUDAMED
Basic UDI-DI
697657818032060052S EUDAMED
697657818032060042Q EUDAMED
EMDN Code
W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

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

Hematology Reagent - Diluent by Wheisman Medical Technology 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
Wheisman Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000045463
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (4)

  • EUDAMED 40e5a464-da1e-4778-bd0d-e5f509ac4ee7 61 fields · synced Jul 31, 2026
  • EUDAMED 04da190a-50ec-4d7a-b164-f03b18581309 61 fields · synced May 17, 2026
  • EUDAMED 0cbf3d2b-5ad6-412c-b068-3af04f6676f1 61 fields · synced May 18, 2026
  • EUDAMED e776fed3-b1df-4f84-bb55-c95b0e5ee716 61 fields · synced May 18, 2026