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Non-esterified Fatty Acid Assay Kit (ACS ACOD Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH060802CModel R1: 20 mL × 1, R2: 5 mL × 1 Calibrator: 1 mL × 1; quality control: 1 mL × 2Ref DTSH060806Model R1: 90 mL × 2, R2: 15 mL × 3Ref DTSH060801CModel R1: 60 mL × 3, R2: 15 mL × 3 Calibrator: 1 mL × 1; quality control: 1 mL × 2Ref DTSH060803Model R1: 60 mL × 1, R2: 15 mL × 1Ref DTSH060805Model R1: 80 mL × 3, R2: 20 mL × 3Ref DTSH060804CModel R1: 40 mL × 3, R2: 30 mL × 1 Calibrator: 1 mL × 1; quality control: 1 mL × 2Ref DTSH060803CModel R1: 60 mL × 1, R2: 15 mL × 1 Calibrator: 1 mL × 1; quality control: 1 mL × 2Ref DTSH060802Model R1: 20 mL × 1, R2: 5 mL × 1
Identity
- Device Name
- Non-esterified Fatty Acid Assay Kit (ACS ACOD Method) EUDAMED
- Model / Reference
- R1: 20 mL × 1, R2: 5 mL × 1 Calibrator: 1 mL × 1; quality control: 1 mL × 2 EUDAMEDDTSH060802C EUDAMEDR1: 90 mL × 2, R2: 15 mL × 3 EUDAMEDDTSH060806 EUDAMEDR1: 60 mL × 3, R2: 15 mL × 3 Calibrator: 1 mL × 1; quality control: 1 mL × 2 EUDAMEDDTSH060801C EUDAMEDR1: 60 mL × 1, R2: 15 mL × 1 EUDAMEDDTSH060803 EUDAMEDR1: 80 mL × 3, R2: 20 mL × 3 EUDAMEDDTSH060805 EUDAMEDR1: 40 mL × 3, R2: 30 mL × 1 Calibrator: 1 mL × 1; quality control: 1 mL × 2 EUDAMEDDTSH060804C EUDAMEDR1: 60 mL × 1, R2: 15 mL × 1 Calibrator: 1 mL × 1; quality control: 1 mL × 2 EUDAMEDDTSH060803C EUDAMEDR1: 20 mL × 1, R2: 5 mL × 1 EUDAMEDDTSH060802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225464132 EUDAMED06975225464224 EUDAMED06975225464194 EUDAMED06975225464149 EUDAMED06975225464200 EUDAMED06975225464170 EUDAMED06975225464156 EUDAMED06975225464125 EUDAMED
- Basic UDI-DI
- B-06975225464132 EUDAMEDB-06975225464224 EUDAMEDB-06975225464194 EUDAMEDB-06975225464149 EUDAMEDB-06975225464200 EUDAMEDB-06975225464170 EUDAMEDB-06975225464156 EUDAMEDB-06975225464125 EUDAMED
- EMDN Code
- W0102010405 LIPOPROTEIN ( A ) 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
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
Non-esterified Fatty Acid Assay Kit (ACS ACOD Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
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-06975225464132 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (8)
- EUDAMED 7fb1ef42-5b73-4011-856e-a3cd9ed45cd1 61 fields · synced Sep 30, 2026
- EUDAMED 595810b1-e52e-45e0-ab37-1b3293e167ed 61 fields · synced May 17, 2026
- EUDAMED 3e702efb-bd52-4ac6-81a2-1b33cdcc627d 61 fields · synced May 17, 2026
- EUDAMED 442855c6-fb1b-44eb-834f-cb314eab1999 61 fields · synced May 17, 2026
- EUDAMED f9a13399-1c36-4841-8d48-fc86e3188abc 61 fields · synced May 17, 2026
- EUDAMED 5ff5ca5d-7e10-4180-9f0e-31c211c3da26 61 fields · synced May 17, 2026
- EUDAMED aca8bd6c-d99d-4232-b0a6-678ccc8e0c96 61 fields · synced May 18, 2026
- EUDAMED 28bdee41-38a6-49aa-ac17-f949b7737d6d 61 fields · synced May 18, 2026