Identity
- Device Name
- LDL DIRECT CHOLESTEROL REAGENT EUDAMED
- Model / Reference
- 02R05-21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08699015281591 EUDAMED
- Basic UDI-DI
- B-08699015281591 EUDAMED
- EMDN Code
- W01010221 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 Direct Cholesterol Reagent by Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ — 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-08699015281591 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000027166
Sources (1)
- EUDAMED 4fcd2a68-f630-4825-9fca-71fb2f0029c6 61 fields · synced Oct 7, 2026