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Non-Esterified Fatty Acid (NEFA) Kit (Enzymatic Method)
EUDAMEDClass IVD General (EU MDR)
Ref 01.09.02.05.EC.01
by Zybio Inc.
Identity
- Device Name
- Non-Esterified Fatty Acid (NEFA) Kit (Enzymatic Method) EUDAMED
- Model / Reference
- 01.09.02.05.EC.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967204169 EUDAMED
- Basic UDI-DI
- B-06941967204169 EUDAMED
- EMDN Code
- W01010222 NON ESTERIFIED FATTY ACIDS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Category: Low density lipoprotein (LDL) cholesterol IVD, reagent
Non-Esterified Fatty Acid (NEFA) Kit (Enzymatic Method) by Zybio Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06941967204169 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 8dbca198-028a-45aa-bc15-b8fdb3c59937 61 fields · synced Jul 17, 2026