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High-density Lipoprotein Cholesterol (HDL-C) Test Kit (Direct-Selective Suppres…
EUDAMEDClass IVD General (EU MDR)
Ref R1:48mL×2 R2:16mL×2(791)
Identity
- Trade Name
- High-density Lipoprotein Cholesterol (HDL-C) Test Kit (Direct-Selective Suppression) EUDAMED
- Device Name
- High-density Lipoprotein Cholesterol (HDL-C) Test Kit (Direct-Selective Suppression) EUDAMED
- Model / Reference
- R1:48mL×2 R2:16mL×2(791) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674860488 EUDAMED
- Basic UDI-DI
- B-06971674860488 EUDAMED
- EMDN Code
- W01010215 HIGH DENSITY LIPOPROTEIN CHOLESTEROL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
High-density Lipoprotein Cholesterol (HDL-C) Test Kit (Direct-Selective Suppres… by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed…
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-06971674860488 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 9fbb4ca3-1e13-4436-a8d2-eedd687e2e9d 61 fields · synced Aug 2, 2026