Identity
- Trade Name
- FE Focus B II EUDAMED
- Device Name
- FE Focus B II EUDAMED
- Model / Reference
- 1×125mL EUDAMED3009374 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794516671 EUDAMED
- Basic UDI-DI
- B-06925794516671 EUDAMED
- EMDN Code
- W010106020602 URINE TESTING CALIBRATORS AND STANDARDS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
FE Focus B II by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06925794516671 | Class IVD General | 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
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 88ca8513-98c3-4773-b6bb-fb1ac32b785a 61 fields · synced Jul 21, 2026