Identity
- Trade Name
- BCC-3000 Cleanser EUDAMED
- Device Name
- Hematology Reagent EUDAMED
- Model / Reference
- 3003088 EUDAMED3019919 EUDAMED3019907 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794501714 EUDAMED06925794577955 EUDAMED06925794577634 EUDAMED
- Basic UDI-DI
- 69257945W0103010105R0LU EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
BCC-3000 Cleanser by Dirui Industrial 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 | 69257945W0103010105R0LU | Class A | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED f06f0dd8-4545-4b4c-950a-c01ad26bc15a 61 fields · synced Aug 4, 2026
- EUDAMED d198971c-a01b-4fdc-8c28-8c8314dea8ef 61 fields · synced Jul 9, 2026
- EUDAMED 25c3d356-9f16-4880-817e-ea07b6f22fb4 61 fields · synced Aug 4, 2026