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Hematology Analyzer
EUDAMEDClass A (EU MDR)
Ref BH-HA310Ref BH-HA600Ref BH-HA340Ref BH-HA350
Identity
- Trade Name
- Hematology Analyzer EUDAMED
- Device Name
- Hematology Analyzer EUDAMED
- Model / Reference
- BH-HA310 EUDAMEDBH-HA600 EUDAMEDBH-HA340 EUDAMEDBH-HA350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974901972206 EUDAMED06974901972251 EUDAMED06974901972220 EUDAMED06974901972237 EUDAMED
- Basic UDI-DI
- 69749019722HA3***8Q 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
- Germany 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 Shandong Bohong Gene 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 | 69749019722HA3***8Q | Class A | Active |
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Manufacturer
- Manufacturer
- Shandong Bohong Gene Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025971
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (4)
- EUDAMED 7307a697-d299-413a-b897-0b086a3406d2 61 fields · synced Aug 1, 2026
- EUDAMED bc49aa79-6b74-4218-a49d-6c76f50fb386 61 fields · synced Jul 22, 2026
- EUDAMED 99f7b356-38d8-4631-9354-ad7870280e13 61 fields · synced Jul 28, 2026
- EUDAMED f4ad6f9e-2709-42e7-8d1d-8a6b3e5686dd 61 fields · synced Aug 1, 2026