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Hematology Reagent - Lyse
EUDAMEDClass A (EU MDR)
Ref 0320900112Model W-61LH：250mL、250mL×3、500mL、500mL×3、1L
Identity
- Trade Name
- Hematology Reagent - Lyse EUDAMED
- Device Name
- Hematology Reagent - Lyse EUDAMED
- Model / Reference
- W-61LH：250mL、250mL×3、500mL、500mL×3、1L EUDAMED0320900112 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976578180410 EUDAMED
- Basic UDI-DI
- 697657818032060032N 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 - Lyse 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697657818032060032N | Class A | Active |
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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 (1)
- EUDAMED b14089e1-ef58-4d95-b411-802aeb269721 61 fields · synced Jun 18, 2026