Identity
- Trade Name
- BF-FBH Lyse EUDAMED
- Device Name
- BF-FBH Lyse EUDAMED
- Model / Reference
- 500mL EUDAMED3019905 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794577917 EUDAMED
- Basic UDI-DI
- 69422022W010301010508R08C EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) 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-FBH Lyse 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 | 69422022W010301010508R08C | 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 (1)
- EUDAMED 8a120f6f-456e-4b04-87ed-dc3b77ba7b5f 61 fields · synced Jul 16, 2026