Identity
- Trade Name
- 5-Part Auto Hematology Analyzer EUDAMED
- Device Name
- 5-Part Auto Hematology Analyzer EUDAMED
- Model / Reference
- BS009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936895300359 EUDAMED
- Basic UDI-DI
- 6936895BS0092J 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
5-Part Auto Hematology Analyzer by Biobase Biodustry(Shandong) 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 | 6936895BS0092J | Class A | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 2b02802e-b3ab-4f6d-b356-614b7e221436 61 fields · synced Jun 18, 2026
- EUDAMED d59d0239-d432-4b22-a9be-24e93a852674 61 fields · synced Jun 18, 2026