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Lipid Testing System
EUDAMEDClass IVD General (EU MDR)
Ref LC-101-1Model LP-101Ref LC-111-1Model LP-102
Identity
- Trade Name
- Lipid Testing System EUDAMED
- Device Name
- Lipid Testing System EUDAMED
- Model / Reference
- LP-101 EUDAMEDLC-101-1 EUDAMEDLP-102 EUDAMEDLC-111-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975519630304 EUDAMED06975519630328 EUDAMED
- Basic UDI-DI
- B-06975519630304 EUDAMEDB-06975519630328 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Lipid Testing System by Hangzhou Bosure Biotech Co., Ltd — 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-06975519630304 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bosure Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000003001
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 4911c26c-2446-4ca8-aeca-b51cb683ba43 61 fields · synced Aug 4, 2026
- EUDAMED e785edfb-4d3e-40f3-8d31-1e6c40cbd4f1 61 fields · synced May 18, 2026