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Hematology Analyzer
EUDAMEDClass A (EU MDR)
Ref HA-5500Model WHY6180，WHY6280，WHY6380，WHY6380S，WHY6580，HA-5000，HA-5500，HA-6000，HA-7006，HA-7003，HA-7004Ref WHY6280Ref HA-5000Ref WHY6380Ref WHY6380SRef WHY6580Ref HA-7003Ref HA-7004Ref HA-6000Ref HA-7006
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 EUDAMEDHA-5500 EUDAMEDWHY6280 EUDAMEDHA-5000 EUDAMEDWHY6380 EUDAMEDWHY6380S EUDAMEDWHY6580 EUDAMEDHA-7003 EUDAMEDHA-7004 EUDAMEDHA-6000 EUDAMEDHA-7006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226450060 EUDAMED06977226450015 EUDAMED06977226450053 EUDAMED06977226450022 EUDAMED06977226450039 EUDAMED06977226450046 EUDAMED06977226450091 EUDAMED06977226450107 EUDAMED06977226450077 EUDAMED06977226450084 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 (10)
- EUDAMED 1638853b-2f12-497a-8b91-6dcd9ef9996c 61 fields · synced Oct 6, 2026
- EUDAMED 005ee608-6737-40ba-819a-09836b6c7ab2 61 fields · synced May 16, 2026
- EUDAMED 68a6ec9d-c688-4b5e-a52b-f97738516a04 61 fields · synced May 17, 2026
- EUDAMED 1051cba0-31ba-45e3-a8f5-a8e4087e18f1 61 fields · synced May 17, 2026
- EUDAMED 09f294cc-dbf1-4218-ad0f-b85cfd9dc753 61 fields · synced May 18, 2026
- EUDAMED 3ae1933e-ef3b-4d76-9b72-9abccd6f94a9 61 fields · synced May 18, 2026
- EUDAMED b83151ed-2541-42b3-a462-8b4e42e287b9 61 fields · synced May 18, 2026
- EUDAMED 5d079f2c-801d-478e-ba08-27ccbd265324 61 fields · synced May 18, 2026
- EUDAMED a444537f-88a8-4d17-8397-e794384a714a 61 fields · synced May 18, 2026
- EUDAMED 581c478e-b814-4597-bfd9-8bf13e37726e 61 fields · synced May 18, 2026