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FE CalibratorⅡ
EUDAMEDClass IVD General (EU MDR)
Ref 3009399Model 1×125 mLRef 3009398Model 1×60 mL
Identity
- Trade Name
- FE CalibratorⅡ EUDAMED
- Device Name
- FE CalibratorⅡ EUDAMED
- Model / Reference
- 1×125 mL EUDAMED3009399 EUDAMED1×60 mL EUDAMED3009398 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794516688 EUDAMED06925794516626 EUDAMED
- Basic UDI-DI
- B-06925794516688 EUDAMEDB-06925794516626 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 CalibratorⅡ 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-06925794516688 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED ab0fafe4-a1a9-4829-98dc-1d0eba2364b1 61 fields · synced Jul 27, 2026
- EUDAMED b0201863-1ec5-4277-a4ec-623def50c868 61 fields · synced May 19, 2026