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FE Control
EUDAMEDClass IVD General (EU MDR)
Ref 3006329Model Level 3 of positive control: 1×60 mLRef 3006334Model Negative control: 1×60 mL
Identity
- Trade Name
- FE Control EUDAMED
- Device Name
- FE Control EUDAMED
- Model / Reference
- Level 3 of positive control: 1×60 mL EUDAMED3006329 EUDAMEDNegative control: 1×60 mL EUDAMED3006334 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794513281 EUDAMED06925794513335 EUDAMED
- Basic UDI-DI
- B-06925794513281 EUDAMEDB-06925794513335 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER 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
EUDAMEDEUDAMED
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 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-06925794513281 | 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 d270c744-33fa-4afd-a27f-d4b70d5704ab 61 fields · synced Jul 14, 2026
- EUDAMED d82bf6dc-45c7-429b-847d-af56f0f0f37f 61 fields · synced May 16, 2026