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CHOLESTEROL Kit
EUDAMEDClass IVD General (EU MDR)
Ref B33080Model CHOLESTEROL Kit 448mLRef B34080Model CHOLESTEROL Kit 250mLRef B28080Model CHOLESTEROL Kit 302mLRef B30080Ref B30081Model CHOLESTEROL Kit 240mLRef B21080Model Cholesterol 432 mLRef B33081Ref B24080Model CHOLESTEROL Kit 90mLRef B29080
Identity
- Trade Name
- CHOLESTEROL Kit EUDAMEDCHOLESTEROL EUDAMEDCHOLESTEROL Kit 90mL EUDAMED
- Device Name
- CHOLESTEROL Kit EUDAMEDCholesterol EUDAMED
- Model / Reference
- CHOLESTEROL Kit 448mL EUDAMEDB33080 EUDAMEDCHOLESTEROL Kit 250mL EUDAMEDB34080 EUDAMEDCHOLESTEROL Kit 302mL EUDAMEDB28080 EUDAMEDB30080 EUDAMEDCHOLESTEROL Kit 240mL EUDAMEDB30081 EUDAMEDCholesterol 432 mL EUDAMEDB21080 EUDAMEDB33081 EUDAMEDCHOLESTEROL Kit 90mL EUDAMEDB24080 EUDAMEDB29080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555615657 EUDAMED08683555616494 EUDAMED08683555618641 EUDAMED08683555614094 EUDAMED08683555614087 EUDAMED08683555610249 EUDAMED08683555615664 EUDAMED08683555613400 EUDAMED08683555614896 EUDAMED
- Basic UDI-DI
- B-08683555615657 EUDAMEDB-08683555616494 EUDAMEDB-08683555618641 EUDAMEDB-08683555614094 EUDAMEDB-08683555614087 EUDAMEDB-08683555610249 EUDAMEDB-08683555615664 EUDAMEDB-08683555613400 EUDAMEDB-08683555614896 EUDAMED
- EMDN Code
- W01010205 CHOLESTEROL 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: Total cholesterol lipid IVD, reagent
CHOLESTEROL Kit by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Total cholesterol lipid IVD, reagent.
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- Teco Diagnostics Cholesterol TC-Matrix-480 — TECO DIAGNOSTICS · Class I
- DIRUI — DIRUI INDUSTRIAL CO., LTD · IVD General
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- Total Cholesterol (TC) — Maccura Biotechnology Co., Ltd. · IVD General
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-08683555615657 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (9)
- EUDAMED 16a37bb5-12da-4695-a2a7-4e9ffe57118f 61 fields · synced Sep 17, 2026
- EUDAMED 067043ad-6d82-4a1c-9adc-eba582213391 61 fields · synced May 17, 2026
- EUDAMED fcdb01be-844b-4d68-83db-5ec51ec107c8 61 fields · synced May 17, 2026
- EUDAMED 439c5b59-f22f-40f8-8e35-809e5cacf331 61 fields · synced May 17, 2026
- EUDAMED 8a2c4759-b4bf-4fc1-8d1b-c8b61e45de9e 61 fields · synced May 18, 2026
- EUDAMED 82f32259-ffd5-4630-a176-1f4ba3f4dce0 61 fields · synced May 18, 2026
- EUDAMED f8cef6fa-aff5-4361-85af-80d2df179c57 61 fields · synced May 18, 2026
- EUDAMED 6b120982-0db8-4b28-9dff-37db0e37cc9a 61 fields · synced May 19, 2026
- EUDAMED 59127133-d456-48f7-a8cc-89d10995d974 61 fields · synced May 19, 2026