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Hematology Analyzer
EUDAMEDClass A (EU MDR)
Ref WHY6180Model WHY6180，WHY6280，WHY6380，WHY6380S，WHY6580，HA-5000，HA-5500，HA-6000，HA-7006，HA-7003，HA-7004
Identity
- Trade Name
- Hematology Analyzer EUDAMED
- Device Name
- Hematology Analyzer EUDAMED
- Model / Reference
- WHY6180，WHY6280，WHY6380，WHY6380S，WHY6580，HA-5000，HA-5500，HA-6000，HA-7006，HA-7003，HA-7004 EUDAMEDWHY6180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226450008 EUDAMED
- Basic UDI-DI
- 697722645BTHA01MF EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) 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
Hematology 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697722645BTHA01MF | Class A | Active |
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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 (1)
- EUDAMED 76152fc8-9409-4c25-9689-6ff94478c47e 61 fields · synced Jun 19, 2026