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Lipoprotein (a) Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass B (EU MDR)
Ref 105-019437-00Model Please see UDI-DI for details
Identity
- Trade Name
- Lipoprotein (a) Kit (Latex Immunoturbidimetric Method) EUDAMED
- Device Name
- Lipoprotein (a) Kit (Latex Immunoturbidimetric Method)、Lipoprotein (a) Calibrator、Lipoprotein (a) Control EUDAMED
- Model / Reference
- Please see UDI-DI for details EUDAMED105-019437-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936415927028 EUDAMED
- Basic UDI-DI
- 69449040004YLpa********BC EUDAMED
- EMDN Code
- W0102010405 LIPOPROTEIN ( A ) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
Category: Apolipoprotein B (Apo B) IVD, reagent
Lipoprotein (a) Kit (Latex Immunoturbidimetric Method) by Shenzhen Mindray Bio-Medical Electronics Co., LTD — Class B — IVDR — listed in EUDAMED
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, reagent.
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- Lipoprotein (a) — Diagam S.A. · IVD General
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- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Lipoprotein (a) Kit (Latex-Enhanced Immunoturbidimetric Method) — MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. · IVD General
- Apolipoprotein B Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- Adenosine Deaminase Assay Kit (Peroxidase Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
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 | 69449040004YLpa********BC | 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 (1)
- EUDAMED cd13098e-b486-4ba8-b482-80802cefea91 61 fields · synced Jul 30, 2026