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Non-Esterified Fatty Acids (nefa)
EUDAMEDClass IVD General (EU MDR)
Ref 11840Ref 12540
Identity
- Device Name
- NON-ESTERIFIED FATTY ACIDS (NEFA) EUDAMED
- Model / Reference
- 11840 EUDAMED12540 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287111767 EUDAMED08435287111774 EUDAMED
- Basic UDI-DI
- B-08435287111767 EUDAMEDB-08435287111774 EUDAMED
- EMDN Code
- W01010222 NON ESTERIFIED FATTY ACIDS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
Category: Low density lipoprotein (LDL) cholesterol IVD, reagent
Non-Esterified Fatty Acids (nefa) by Biosystems S.a. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Low density lipoprotein (LDL) cholesterol IVD, reagent.
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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-08435287111767 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED f195a81c-3681-426e-8d9d-b0a3125cb770 61 fields · synced Aug 3, 2026
- EUDAMED 7a332596-c31f-49a8-8213-788340f293a4 61 fields · synced May 17, 2026