Identity
- Trade Name
- Diluent(BCC-3000) EUDAMEDDiluent EUDAMED
- Device Name
- Hematology Reagent EUDAMED
- Model / Reference
- 3003090 EUDAMED3019976 EUDAMED3019977 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794501721 EUDAMED06925794577924 EUDAMED06925794577733 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
Diluent(BCC-3000) 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 925b8d6c-3bcd-46f9-86c0-715c5773ddfa 61 fields · synced Jul 29, 2026
- EUDAMED e2e076ab-bc0c-4470-9ec6-ecea51a121d0 61 fields · synced Jul 9, 2026
- EUDAMED cb09ebc3-3dcc-4e6b-aaba-094a10c137aa 61 fields · synced Jul 29, 2026