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LDL - Cholesterol Kit
EUDAMEDClass IVD General (EU MDR)
Ref B29222Model LDL - Cholesterol Kit 72mLRef B28221Model LDL-CHOLESTEROL Kit 165mLRef B27222Model LDL - Cholesterol Kit 74mLRef B30222Ref B21221Model LDL-Cholesterol 222 mLRef B21223Model LDL - Cholesterol 222 mLRef B30221Model LDL - Cholesterol Kit 216mL Ref B35220Model LDL-CHOLESTEROL Kit 120mLRef B22220Model LDL - Cholesterol 144 mLRef B35221EModel LDL-CHOLESTEROL Kit 80mLRef B27221Model LDL - Cholesterol Kit 220mLRef B21220Model LDL-Cholesterol Kit 444mLRef B34221Model LDL-CHOLESTEROL Kit 96mLRef B27220Model LDL - Cholesterol Kit 444mLRef B33221Model LDL-CHOLESTEROL Kit 216mL
Identity
- Trade Name
- LDL - Cholesterol Kit EUDAMEDLDL-CHOLESTEROL Kit EUDAMEDLDL-Cholesterol EUDAMEDLDL - Cholesterol EUDAMED
- Device Name
- LDL - Cholesterol Kit EUDAMEDLDL-CHOLESTEROL Kit EUDAMEDLDL-Cholesterol EUDAMEDLDL - Cholesterol EUDAMED
- Model / Reference
- LDL - Cholesterol Kit 72mL EUDAMEDB29222 EUDAMEDLDL-CHOLESTEROL Kit 165mL EUDAMEDB28221 EUDAMEDLDL - Cholesterol Kit 74mL EUDAMEDB27222 EUDAMEDB30222 EUDAMEDLDL-Cholesterol 222 mL EUDAMEDB21221 EUDAMEDLDL - Cholesterol 222 mL EUDAMEDB21223 EUDAMEDLDL - Cholesterol Kit 216mL EUDAMEDB30221 EUDAMEDLDL-CHOLESTEROL Kit 120mL EUDAMEDB35220 EUDAMEDLDL - Cholesterol 144 mL EUDAMEDB22220 EUDAMEDLDL-CHOLESTEROL Kit 80mL EUDAMEDB35221E EUDAMEDLDL - Cholesterol Kit 220mL EUDAMEDB27221 EUDAMEDLDL-Cholesterol Kit 444mL EUDAMEDB21220 EUDAMEDLDL-CHOLESTEROL Kit 96mL EUDAMEDB34221 EUDAMEDLDL - Cholesterol Kit 444mL EUDAMEDB27220 EUDAMEDLDL-CHOLESTEROL Kit 216mL EUDAMEDB33221 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683555601520 EUDAMED08683555601919 EUDAMED08683555600134 EUDAMED08683555601452 EUDAMED08683555610744 EUDAMED08683555610768 EUDAMED08683555614490 EUDAMED08683555617491 EUDAMED08683555612175 EUDAMED08683555601759 EUDAMED08683555612991 EUDAMED08683555610737 EUDAMED08683555616807 EUDAMED08683555612984 EUDAMED08683555616050 EUDAMED
- Basic UDI-DI
- B-08683555601520 EUDAMEDB-08683555601919 EUDAMEDB-08683555600134 EUDAMEDB-08683555601452 EUDAMEDB-08683555610744 EUDAMEDB-08683555610768 EUDAMEDB-08683555614490 EUDAMEDB-08683555617491 EUDAMEDB-08683555612175 EUDAMEDB-08683555601759 EUDAMEDB-08683555612991 EUDAMEDB-08683555610737 EUDAMEDB-08683555616807 EUDAMEDB-08683555612984 EUDAMEDB-08683555616050 EUDAMED
- EMDN Code
- W0101060111 LDL TEST STRIPS EUDAMEDW01010221 LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL 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
LDL - Cholesterol Kit by Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇ — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-08683555601520 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ki̇neti̇k Bi̇li̇şi̇m Di̇agnosti̇k Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000040334
Sources (15)
- EUDAMED bab2ceac-1126-4939-bb93-b8753ab8e270 61 fields · synced Oct 6, 2026
- EUDAMED b99c2e8a-735b-4bdd-95dc-7594e501d911 61 fields · synced May 16, 2026
- EUDAMED 6923049e-da5f-4230-b40d-4a2d643957bc 61 fields · synced May 17, 2026
- EUDAMED 5af438d3-6e05-4512-b6fb-323f34ab1680 61 fields · synced May 17, 2026
- EUDAMED 03d68829-4b3d-4b3e-ad47-ddafe5f66b22 61 fields · synced May 17, 2026
- EUDAMED dc7a18c8-d20e-4f6e-9e3d-b45a8862d302 61 fields · synced May 17, 2026
- EUDAMED a88cf656-7342-4cf8-ab8f-a69936c165cd 61 fields · synced May 17, 2026
- EUDAMED c5767255-83f4-4f4b-b4d0-f85579767079 61 fields · synced May 17, 2026
- EUDAMED c2452018-8de9-4ff0-93ec-d306fec7fa32 61 fields · synced May 18, 2026
- EUDAMED 4b4988ca-13f9-4dce-ae4d-29020f3bc087 61 fields · synced May 18, 2026
- EUDAMED 9e41165e-7039-4e99-80ff-9d79f3b3c79e 61 fields · synced May 18, 2026
- EUDAMED 5998f04c-329d-4b9f-b051-3b9d399de1eb 61 fields · synced May 18, 2026
- EUDAMED b5b3385b-a21e-484e-81de-0397defda6b6 61 fields · synced May 18, 2026
- EUDAMED 19e4ab07-48a3-48d0-9251-5ae4e6a4757b 61 fields · synced May 18, 2026
- EUDAMED 0a0e3ab8-f4cb-4e24-b794-f5040ed9a777 61 fields · synced May 19, 2026