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Non-esterified Fatty Acid (NEFA) Test Kit (ACS-PAP)
EUDAMEDClass IVD General (EU MDR)
Ref Calibrator：1mL×1（91058）Ref Quality Control：1mL×1（92049）Ref R1:20mL×4 R2:5mL×4（709）
Identity
- Trade Name
- Non-esterified Fatty Acid (NEFA) Test Kit (ACS-PAP) EUDAMED
- Device Name
- Non-esterified Fatty Acid (NEFA) Test Kit (ACS-PAP) EUDAMED
- Model / Reference
- Calibrator：1mL×1（91058） EUDAMEDQuality Control：1mL×1（92049） EUDAMEDR1:20mL×4 R2:5mL×4（709） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674868156 EUDAMED06971674868521 EUDAMED06971674869771 EUDAMED
- Basic UDI-DI
- B-06971674868156 EUDAMEDB-06971674868521 EUDAMEDB-06971674869771 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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: Nucleic acid extraction/isolation kit IVD
Non-esterified Fatty Acid (NEFA) Test Kit (ACS-PAP) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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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-06971674868156 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (3)
- EUDAMED 6d3c1e31-9fda-47df-b6af-4513899b63a7 61 fields · synced Oct 6, 2026
- EUDAMED 621d5672-9464-446f-970c-72acab8987fe 61 fields · synced May 17, 2026
- EUDAMED 079f3753-7bbc-4e30-b1c9-61edba89c76c 61 fields · synced May 18, 2026