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Total Cholesterol Kit (CHOD-POD Method)
EUDAMEDClass B (EU MDR)
Ref 105-001595-00Model 105-000820-00、105-000859-00、105-001595-00Ref 105-000859-00
Identity
- Trade Name
- Total Cholesterol Kit (CHOD-POD Method) EUDAMED
- Device Name
- Total Cholesterol Kit (CHOD-POD Method) EUDAMED
- Model / Reference
- 105-000820-00、105-000859-00、105-001595-00 EUDAMED105-001595-00 EUDAMED105-000859-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904026152 EUDAMED06944904025155 EUDAMED
- Basic UDI-DI
- 694490400041TC*********W6 EUDAMED
- EMDN Code
- W01010205 CHOLESTEROL EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Category: Total cholesterol lipid IVD, reagent
Total Cholesterol Kit (CHOD-POD Method) by Shenzhen Mindray Bio-Medical Electronics Co., LTD — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Total cholesterol lipid IVD, reagent.
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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 | 694490400041TC*********W6 | Class B | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 74a4ae07-b2cc-402b-8da3-7aa19d0fe187 61 fields · synced Jul 9, 2026
- EUDAMED ef253604-f401-4756-b5ca-53092cfe0756 61 fields · synced May 18, 2026