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BH-7600CS、BH-7610CS、 BH-7620CS、BH-7630CS、 BH-7660CS、 BH-7680CS、BH-7680、BH-7600 …
EUDAMEDClass IVD General (EU MDR)
Ref /Model BH-7600CS、BH-7610CS、 BH-7620CS、BH-7630CS、 BH-7660CS、 BH-7680CS、BH-7680、BH-7600
Identity
- Trade Name
- BH-7600CS、BH-7610CS、 BH-7620CS、BH-7630CS、 BH-7660CS、 BH-7680CS、BH-7680、BH-7600 5-Part-Diff Auto Hematology Analyzer EUDAMED
- Device Name
- 5-Part-Diff Auto Hematology Analyzer EUDAMED
- Model / Reference
- BH-7600CS、BH-7610CS、 BH-7620CS、BH-7630CS、 BH-7660CS、 BH-7680CS、BH-7680、BH-7600 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-2-96P EUDAMED
- Basic UDI-DI
- B-2-96P EUDAMED
- EMDN Code
- W0202010102 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 120 samples/hr) EUDAMED
Classification
- Device Class
- Class IVD General 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
BH-7600CS、BH-7610CS、 BH-7620CS、BH-7630CS、 BH-7660CS、 BH-7680CS、BH-7680、BH-7600 … by URIT Medical Electronic Co., Ltd. — Class IVD General — IVDD — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-2-96P | Class IVD General | 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 cf69cdc1-f14e-4a4f-b764-39a8862e2df6 61 fields · synced Oct 6, 2026