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FE ControlⅡNegative Control
EUDAMEDClass IVD General (EU MDR)
Ref 3009394Model Negative control: 1×125mLRef 3009393Model Negative control: 1×60mL
Identity
- Trade Name
- FE ControlⅡNegative Control EUDAMED
- Device Name
- FE ControlⅡNegative Control EUDAMED
- Model / Reference
- Negative control: 1×125mL EUDAMED3009394 EUDAMEDNegative control: 1×60mL EUDAMED3009393 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794516725 EUDAMED06925794516664 EUDAMED
- Basic UDI-DI
- B-06925794516725 EUDAMEDB-06925794516664 EUDAMED
- EMDN Code
- W010106020601 URINE TESTING CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General 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
FE ControlⅡNegative Control 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-06925794516725 | 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 363ce2dc-0af2-4e3c-b048-4e50d88971d9 61 fields · synced Jul 9, 2026
- EUDAMED 3ae32411-ba53-45be-aa2f-c04487b2e0ea 61 fields · synced May 16, 2026