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Lipid test devices
EUDAMEDClass IVD General (EU MDR)
Ref LS-131-2Model LS-104Ref LS-101-2Model LS-101Ref LS-121-2Model LS-103
Identity
- Trade Name
- Lipid test devices EUDAMED
- Device Name
- Lipid test devices EUDAMED
- Model / Reference
- LS-104 EUDAMEDLS-131-2 EUDAMEDLS-101 EUDAMEDLS-101-2 EUDAMEDLS-103 EUDAMEDLS-121-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975519630298 EUDAMED06975519630236 EUDAMED06975519630274 EUDAMED
- Basic UDI-DI
- B-06975519630298 EUDAMEDB-06975519630236 EUDAMEDB-06975519630274 EUDAMED
- EMDN Code
- W0101060105 TRIGLYCERIDE TEST STRIPS EUDAMEDW0101060109 MULTIPLE PARAMETER BLOOD TEST EUDAMEDW0101060103 HDL TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDRomania 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
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Lipid test devices 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-06975519630298 | 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 (3)
- EUDAMED 47eec630-3a55-4900-bcf1-319b18c65113 61 fields · synced Aug 3, 2026
- EUDAMED c6e07b1c-3b04-410e-aa73-73222a6de7a4 61 fields · synced May 17, 2026
- EUDAMED f9743630-598e-42b5-ab3e-d7b08ec51eee 61 fields · synced May 19, 2026