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Centrifuge
EUDAMEDClass A (EU MDR)
Ref 80-2ARef LSC-412DRef LSC-408TRef CEN-412MRef 800D
Identity
- Device Name
- CENTRIFUGE EUDAMED
- Model / Reference
- 80-2A EUDAMEDLSC-412D EUDAMEDLSC-408T EUDAMEDCEN-412M EUDAMED800D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977889900018 EUDAMED06977889900032 EUDAMED06977889900025 EUDAMED06977889900063 EUDAMED06977889900001 EUDAMED
- Basic UDI-DI
- 697788990RJLSC7P EUDAMED
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye 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
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: General-purpose centrifuge IVD
Centrifuge by Changzhou Richgenius Medlab Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose centrifuge IVD.
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- 406 — GYROZEN · Class A
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 | 697788990RJLSC7P | Class A | Active |
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Manufacturer
- Manufacturer
- Changzhou Richgenius Medlab Co., Ltd
- EUDAMED SRN
- CN-MF-000051661
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 574626a0-42f4-4823-bd64-d033e8cb7a65 61 fields · synced Jul 12, 2026
- EUDAMED eb49ef5b-e186-48b1-990a-07e5f1c3d0ee 61 fields · synced May 17, 2026
- EUDAMED ee16bbf3-383c-4960-b57e-7211dcc1db51 61 fields · synced May 17, 2026
- EUDAMED ec113fc2-f275-43ef-983d-e4bedf8fc914 61 fields · synced May 17, 2026
- EUDAMED b05a0aa0-a440-4527-bb7e-23ced87cde8e 61 fields · synced May 18, 2026