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Triglycerides
EUDAMEDClass IVD General (EU MDR)
Ref B21280Model Triglycerides 432 mL
Identity
- Trade Name
- Triglycerides EUDAMED
- Device Name
- Triglycerides EUDAMED
- Model / Reference
- Triglycerides 432 mL EUDAMEDB21280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555610959 EUDAMED
- Basic UDI-DI
- B-08683555610959 EUDAMED
- EMDN Code
- W01010231 TRIGLYCERIDES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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: Triglyceride IVD, reagent
Triglycerides by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — Class IVD General — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Triglyceride IVD, reagent.
- Triglycerides – Liquizyme GPO-PAP (Single Reagent) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- Triglycerides – Liquizyme GPO-PAP (Single Reagent) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- Triglycerides Kit (GPO-POD Method) — Shenzhen Mindray Bio-Medical Electronics Co.,LTD · Class B
- ΤΡΙΓΛΥΚΕΡΙΔΙΑ LIQUID 8x45 ml (UR8210/PPC300N) — Biotechnological Applications Ltd · IVD General
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- Triglycerides (TG) Assay Kit (Enzymatic Method) — YHLO BIOTECH (NANJING) CO., LTD. · IVD General
- TRIGLYCERIDES — Medicon Hellas SA · Class B
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-08683555610959 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (1)
- EUDAMED 4df96a66-948a-4558-88b5-c2f45321df52 61 fields · synced Oct 6, 2026