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Hematology Reagent - Lyse
EUDAMEDClass A (EU MDR)
Ref 0320900108Model W-61LD：250mL、250mL×3、500mL、500mL×3、1LRef 0320900107Ref 0320900119Model W-31L：250mL、250mL×3、500mL、500mL×3、1LRef 0320900104Ref 0320900106Ref 0320900109Model W-61LH：250mL、250mL×3、500mL、500mL×3、1LRef 0320900110Ref 0320900120
Identity
- Trade Name
- Hematology Reagent - Lyse EUDAMED
- Device Name
- Hematology Reagent - Lyse EUDAMED
- Model / Reference
- W-61LD：250mL、250mL×3、500mL、500mL×3、1L EUDAMED0320900108 EUDAMED0320900107 EUDAMEDW-31L：250mL、250mL×3、500mL、500mL×3、1L EUDAMED0320900119 EUDAMED0320900104 EUDAMED0320900106 EUDAMEDW-61LH：250mL、250mL×3、500mL、500mL×3、1L EUDAMED0320900109 EUDAMED0320900110 EUDAMED0320900120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976578180458 EUDAMED06976578180427 EUDAMED06976578180519 EUDAMED06976578180052 EUDAMED06976578180441 EUDAMED06976578180397 EUDAMED06976578180403 EUDAMED06976578180526 EUDAMED
- Basic UDI-DI
- 697657818032060022L EUDAMED697657818032060012J EUDAMED697657818032060032N 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 | 697657818032060022L | 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 (8)
- EUDAMED ccfb2934-8ea3-4546-a62f-ab402196b617 61 fields · synced Jul 28, 2026
- EUDAMED 086280ae-07cb-4927-8f52-35b856d54764 61 fields · synced May 11, 2026
- EUDAMED 04b3262d-4165-4efa-9820-61c5933fea7d 61 fields · synced May 17, 2026
- EUDAMED 8e600b56-e8f4-4cc1-bdfb-61be266ef5be 61 fields · synced May 17, 2026
- EUDAMED 56628536-d28a-49ec-ab99-9ac467e2c61f 61 fields · synced May 17, 2026
- EUDAMED cc5f1ea6-7bc7-495f-8093-d81db215cf5f 61 fields · synced May 18, 2026
- EUDAMED 7fc4f442-4263-4723-9c18-bc275658157f 61 fields · synced May 19, 2026
- EUDAMED 5b53efea-5e9e-44e7-862f-223f179750ad 61 fields · synced May 19, 2026