Identity
- Trade Name
- BF-WNF Dye EUDAMED
- Device Name
- Hematology Reagent EUDAMED
- Model / Reference
- 3014301 EUDAMED3019951 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794523495 EUDAMED06925794577894 EUDAMED
- Basic UDI-DI
- 69257945W0103010199R0PF EUDAMED
- EMDN Code
- W0103010199 REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
BF-WNF Dye 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 | 69257945W0103010199R0PF | 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 (2)
- EUDAMED b0e15614-93cf-4a6a-890a-ab69616281f6 61 fields · synced Jul 31, 2026
- EUDAMED b114d1d8-c318-47db-a559-0212d1566d1e 61 fields · synced Jul 31, 2026