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FE ControlⅡPositive Control
EUDAMEDClass IVD General (EU MDR)
Ref 3009389Model Level 3: 1×125 mL
Identity
- Trade Name
- FE ControlⅡPositive Control EUDAMED
- Device Name
- FE ControlⅡPositive Control EUDAMED
- Model / Reference
- Level 3: 1×125 mL EUDAMED3009389 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794516718 EUDAMED
- Basic UDI-DI
- B-06925794516718 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
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 ControlⅡPositive 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-06925794516718 | 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 (1)
- EUDAMED 9c4efdf8-12a9-445b-86ad-957783534a1f 61 fields · synced Jun 18, 2026