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Lipid Control Serum
EUDAMEDClass IVD General (EU MDR)
Ref 3003163Model Level1: 1×1mLRef 3003165Model Level1: 3×1mLRef 3003171Model Level2: 3×1mL
Identity
- Trade Name
- Lipid Control Serum EUDAMED
- Device Name
- Lipid Control Serum EUDAMED
- Model / Reference
- Level1: 1×1mL EUDAMED3003163 EUDAMEDLevel1: 3×1mL EUDAMED3003165 EUDAMEDLevel2: 3×1mL EUDAMED3003171 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202247224 EUDAMED06942202247231 EUDAMED06942202247255 EUDAMED
- Basic UDI-DI
- B-06942202247224 EUDAMEDB-06942202247231 EUDAMEDB-06942202247255 EUDAMED
- EMDN Code
- W0101050202 LIPID CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Lipid Control Serum by Dirui Industrial 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-06942202247224 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 83cd5a40-72f3-4169-98c1-21d17d3fe165 61 fields · synced Aug 3, 2026
- EUDAMED c5f56c22-f7ac-4a6d-88f7-d9e86e8cea9d 61 fields · synced May 17, 2026
- EUDAMED 04bd8900-5a78-45df-a8df-3b04636fcdbc 61 fields · synced May 17, 2026