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BH-6180 5-Part-Diff Auto Hematology Analyzer
EUDAMEDClass B (EU MDR)
Ref /Model BH-6180、BH-6580、BH-6680、BH-6600、BH-6500、BH-6100
Identity
- Trade Name
- BH-6180 5-Part-Diff Auto Hematology Analyzer EUDAMED
- Device Name
- 5-Part-Diff Auto Hematology Analyzer EUDAMED
- Model / Reference
- BH-6180、BH-6580、BH-6680、BH-6600、BH-6500、BH-6100 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740730433 EUDAMED
- Basic UDI-DI
- 69357407IBH000004ND EUDAMED
- Direct Marketing DI
- 06935740730433 EUDAMED
- EMDN Code
- W0202010102 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr) EUDAMED
Classification
- Device Class
- Class B 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
BH-6180 5-Part-Diff Auto Hematology Analyzer by URIT Medical Electronic Co., Ltd. — Class B — 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 | 69357407IBH000004ND | Class B | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 586d4600-0dc0-4ae3-9800-f735ec2e3a50 61 fields · synced Oct 7, 2026