Identity
- Trade Name
- Sigma 1-16K EUDAMED
- Device Name
- Sigma laboratory centrifuge IVD EUDAMED
- Model / Reference
- 10054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260734390099 EUDAMED
- Basic UDI-DI
- 426073439IVD01001JQCJ4 EUDAMED
- Direct Marketing DI
- 04260734390099 EUDAMED
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Sigma 1-16K by Sigma Laborzentrifugen GmbH — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 426073439IVD01001JQCJ4 | Class A | Active |
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Manufacturer
- Manufacturer
- Sigma Laborzentrifugen GmbH
- EUDAMED SRN
- DE-MF-000009414
Sources (1)
- EUDAMED 0f06c117-104f-4841-a370-6c30f8b17620 61 fields · synced Jun 19, 2026