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Hematology Analyzer
EUDAMEDClass A (EU MDR)
Ref 80100 80120 80300 80310 80320 80330 80340 8035080200 80500 80301 80400 80600 80900 80910 80920 80930 80360 80370 80380 Model Hemax320 Hemax330 Hemax330AL Hemax330P/C Hemax330Vet Hemax33 Hemax33P/C Hemax530AL Hemax530 Hemax530CT Hemax531 Hemax532 Hemax53 Hemax53CT Hemax53+Fi Hemax53+Cap Hemax53+Cap+Fi Hemax53+CT+Fi Hemax53+Cap+CT Hemax53+Cap+CT+Fi Hemax53AL+Fi
Identity
- Trade Name
- Hematology Analyzer EUDAMED
- Device Name
- Hematology Analyzer EUDAMED
- Model / Reference
- Hemax320 Hemax330 Hemax330AL Hemax330P/C Hemax330Vet Hemax33 Hemax33P/C Hemax530AL Hemax530 Hemax530CT Hemax531 Hemax532 Hemax53 Hemax53CT Hemax53+Fi Hemax53+Cap Hemax53+Cap+Fi Hemax53+CT+Fi Hemax53+Cap+CT Hemax53+Cap+CT+Fi Hemax53AL+Fi EUDAMED80100 80120 80300 80310 80320 80330 80340 8035080200 80500 80301 80400 80600 80900 80910 80920 80930 80360 80370 80380 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972337850037 EUDAMED
- Basic UDI-DI
- 697233785HemaA0024Y EUDAMED
- EMDN Code
- W0202010101,W0202010201 EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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 B&E Bio-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 | 697233785HemaA0024Y | Class A | Active |
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Manufacturer
- Manufacturer
- B&E Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000023256
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 28632f0a-4954-4ea6-af37-fb7aca69356b 61 fields · synced Jul 12, 2026