Identity
- Trade Name
- Sigma 8KBS EUDAMED
- Device Name
- centrifuge for blood compoments separation EUDAMED
- Model / Reference
- 10635 EUDAMED10636 EUDAMED91302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260734390013 EUDAMED04260734390020 EUDAMED04260734390037 EUDAMED
- Basic UDI-DI
- 426073439MD01001KSOHH EUDAMED
- Direct Marketing DI
- 04260734390013 EUDAMED04260734390020 EUDAMED04260734390037 EUDAMED
- EMDN Code
- W02069005 REFRIGERATED CENTRIFUGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sigma 8KBS by Sigma Laborzentrifugen GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426073439MD01001KSOHH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sigma Laborzentrifugen GmbH
- EUDAMED SRN
- DE-MF-000009414
Sources (3)
- EUDAMED 0895e4aa-c75c-44d8-a29d-b68f8572201f 61 fields · synced Jul 16, 2026
- EUDAMED 55883cf7-be46-48cc-883a-9d61c7e417ff 61 fields · synced Jun 14, 2026
- EUDAMED bb2cf55d-c0fa-405e-b63b-6f858578ead8 61 fields · synced Jul 16, 2026